Product Problem
abnormal
aborted charge
absorption
accessory incompatible
activation failure
activation problem
activation, positioning or separation problem
adaptor, failure of
adhesive too strong
adverse event without identified device or use problem
air eliminator, defective
air leak
air/gas in device
alarm not visible
alarm system, failure of check-catheter
alarm system, failure of gas-leak/loss
alarm system, failure of message-battery status
alarm, audible
alarm, error of warning
alarm, failure of warning
alarm, intermittent
alarm, no lead
altitude variations
ambient noise problem
ambient temperature problem
antenna, failure of
application interface becomes non-functional or program exits abnormally
application network problem
application program freezes, becomes nonfunctional
application program problem
application program problem: dose calculation error
application program problem: medication error
application program problem: parameter calculation error
application program problem: power calculation error
application program version or upgrade problem
application security problem
applicator failure
appropriate term/code not available
arcing
arcing at paddles
arcing of electrodes
aspiration issue
aspiration, excessive
aspiration, incomplete
audible prompt/feedback problem
automatic injection system overinfusion
backflow
balloon asymmetrical
balloon burst
balloon leak(s)
balloon mushroomed
balloon pinhole
balloon rupture
battery charger, defective
battery failure
battery impedance issue
battery problem
battery problem: high impedance
battery problem: low impedance
bent
bicarbonate
biocompatibility
biofilm coating in device
biological environmental factor
blank screen
blocked connection
blood gas measurements, erroneous
blood in tubing
blood pooling
bolus mechanism failure
break
bubble(s)
burn hole(s)
burst container or vessel
cable break
cable, defective
calcified
calibration error
calibration problem
cannula guide, needle insertion difficult
capacitative coupling
capturing problem
carbon absorption
cardiac enzyme evaluation, erroneous
cautery
central regurgitation
changes in ambient temperature in device environment
channeling
charging problem
charred
chemical problem
chemical spillage
circuit breaker tripped
circuit failure
clips, scissored
close, difficult to
clumping in device or device ingredient
coagulation in device or device ingredient
coiled
collapse
collimator design problem
color variation, lens
communication or transmission problem
compatibility
compatibility problem
complete blockage
complete loss of power
component falling
component incompatible
component misassembled
component missing
component or accessory incompatibility
component(s), broken
component(s), overheating of
component(s), worn
computer failure
computer hardware error
computer operating system problem
computer software problem
computer system security problem
conductivity
connection error
connection problem
contamination
contamination /decontamination problem
contamination of device ingredient or reagent
continuous firing
cool, failure to
corroded
couple, failure to
crack
cross connection
cross reactivity
cuff degeneration
cut in material
cutoff point
cutter-torque-cable twisted or tangled
data back-up problem
data problem
date/time-related software problem
decoupling
decrease in pressure
decrease in suction
decreased pump speed
decreased sensitivity
defective alarm
defective component
defective device
defibrillation/stimulation problem
deflation due to trauma
deflation problem
deflation, cause unknown
deformation due to compressive stress
degraded
delamination
delayed alarm
delayed charge time
delayed program or algorithm execution
delivered as unsterile product
delivery system failure
delivery system issue, no description
dent in material
deprimed
design/structure problem
detachment of device component
detachment of device or device component
deterioration of prosthesis
device abrasion from instrument or another object
device alarm system
device appears to trigger rejection
device contaminated at the user facility
device contaminated during manufacture or shipping
device contamination with biological material
device contamination with body fluid
device contamination with chemical or other material
device damaged by another device
device damaged prior to use
device difficult to maintain
device difficult to program or calibrate
device difficult to setup or prepare
device disinfection or sterilization issue
device dislodged or dislocated
device displays incorrect message
device emits odor
device expiration issue
device fell
device handling problem
device ingredient or reagent problem
device inoperable
device issue
device maintenance issue
device markings/labelling problem
device misassembled during manufacturing /shipping
device operates differently than expected
device operational issue
device or device fragments location unknown
device packaging compromised
device remains activated
device remains implanted
device reprocessing problem
device rinsing issue
device sensing problem
device slipped
device stenosis
device stops intermittently
device tipped over
device unsafe to use in environment
device, or device fragments remain in patient
device, removal of (non-implant)
device-device incompatibility
difficult or delayed activation
difficult or delayed positioning
difficult or delayed separation
difficult to advance
difficult to flush
difficult to fold, unfold or collapse
difficult to insert
difficult to interrogate
difficult to open or close
difficult to open or remove packaging material
difficult to position
difficult to remove
disassembly
disconnection
disengaged
dislocated
dislodged
displacement
display difficult to read
display or visual feedback problem
disposable
dissection
distilled water, contaminated
dome collapse
drift
dull, blunt
ejection problem
ekg/ecg analysis, failure to perform
elective removal
elective replacement
electrical /electronic property problem
electrical overstress
electrical power problem
electrical shorting
electrical wires, defective
electro-magnetic interference (emi), compatibility/incompatibility
electro-static discharge
electrode(s), failure of
electrode(s), fracture of
electromagnetic compatibility problem
electromagnetic interference
electronic property issue
emergency power failure
emergency stop button or switch failure
energy output problem
energy output to patient tissue incorrect
energy spectrum incorrect
entrapment of device
environmental compatibility problem
environmental particulates
erratic or intermittent display
erratic results
error or warning message, failure to produce
escape
excess flow or over-infusion
excessive cooling
excessive heating
expiration date error
explanted
explode
explosion
expulsion
external fiberoptic break
extra components
extrusion
facilities issue
fail-safe design failure
fail-safe did not operate
fail-safe problem
failure of device to self-test
failure to adhere or bond
failure to advance
failure to align
failure to analyze signal
failure to auto stop
failure to back-up
failure to calibrate
failure to capture
failure to charge
failure to clean adequately
failure to conduct
failure to convert rhythm
failure to convert to back-up
failure to cut
failure to cycle
failure to deflate
failure to deliver
failure to deliver energy
failure to deliver shock/stimulation
failure to discharge
failure to disconnect
failure to disinfect
failure to eject
failure to fire
failure to fold
failure to form staple
failure to infuse
failure to interrogate
failure to obtain sample
failure to osseointegrate
failure to power up
failure to prime
failure to pump
failure to read input signal
failure to recalibrate
failure to reset
failure to run on ac/dc
failure to run on battery
failure to seal
failure to select signal
failure to sense
failure to service
failure to shut off
failure to transmit record
failure to unfold or unwrap
failure to unwrap
failure to zero
failure, intermittent
false alarm
false claim
false device output
false negative result
false positive result
false reading from device non-compliance
fiberoptic break/separation
fiberoptic cladding material separation
fibrosis
filling problem
film processing, inadequate
filter
filter break(s)
filter leak(s)
filter tear(s)
filter, inadequate
filtration problem
fire
firing problem
fitting problem
flaked
flammable
flare or flash
flashpoint threshold met
fluid/blood leak
flushing problem
fogging
folded
folding issue
foreign material
fracture
free or unrestricted flow
fumes or vapors
function indicator light(s), failure of
fungus in device environment
fuse, blown
gas delivery system failure
gas output problem
gas/air leak
gel leak
glass, shattered
gradient increase
grounding malfunction
handpiece break
handrest break
haptic damaged in delivery system
haptic(s), bent
haptic(s), broken
heat
heat, failure to
hermetic seal, loss of
high capture threshold
high flux rate
high impedance
high ph
high readings
high sensing threshold
high test results
hole in material
hose line occlusion
hose line rupture
hot oil leak
human factors issue
human-device interface problem
hybrid failure
illegible information
image display error/artifact
image orientation incorrect
image resolution poor
image reversal
impedance problem
implant breakage or physical damage
implant extrusion
implant mobility nos (not otherwise specified)
implant, removal of
implant, repositioning of
imprecision
improper alarm
improper chemical reaction
improper device output
improper flow or infusion
improper or incorrect procedure or method
inability to auto-fill
inability to irrigate
inaccurate delivery
inaccurate dispensing
inaccurate flow rate
inaccurate information
inaccurate synchronization
inadequacy of device shape and/or size
inadequate filtration process
inadequate instructions for healthcare professional
inadequate instructions for non-healthcare professional
inadequate lighting
inadequate lubrication
inadequate or insufficient training
inadequate service
inadequate storage
inadequate ultra filtration
inadequate user interface
inappropriate audible prompt/feedback
inappropriate or unexpected reset
inappropriate tactile prompt/feedback
inappropriate waveform
inappropriate/inadequate shock/stimulation
inaudible or unclear audible prompt/feedback
incomplete coaptation
incomplete or inadequate connection
incomplete or inadequate priming
incomplete or missing packaging
incorrect device or component shipped
incorrect error code
incorrect interpretation of signal
incorrect measurement
incorrect or inadequate test results
incorrect software programming calculations
incorrect, inadequate or imprecise result or readings
increase in pressure
increase in suction
increased pump speed
increased sensitivity
inflation problem
infusion or flow problem
installation error
installation-related problem
insufficient cooling
insufficient flow or under infusion
insufficient heating
insufficient information
insulation degradation
insulation failure
insulation, detached
insulation, discolored
insulation, hole(s) in
intended use for traditional use
interference
interference with monitoring device
interference with pacemaker
intermittent capture
intermittent communication failure
intermittent continuity
intermittent energy output
intermittent infusion
intermittent loss of power
intermittent program or algorithm execution
intermittent shock/stimulation
internal fixation, revision of
interrogation problem
intra-cavity procedure, fiberoptic break or fragmentation during
intraprocedure, fire or flash during
invalid sensing
issue with displayed error message
iud (intrauterine contraceptive device), removal of
key or button unresponsive/not working
kinetic
kinked
knotted
labeling, missing
labelling, instructions for use or training problem
lack of effect
lack of maintenance documentation or guidelines
laser output, unintended
laser pulse timing error
laser tip separation
lead(s), breakage of
lead(s), burn(s) from
lead(s), fracture of
lead(s), shock from
leaflet disc escape
leaflet disruption, cause unknown
leaflet fracture
leak/splash
lens (iol), defective, problem not specified
lens (iol), dislocated intraocular
lens (iol), migration of intraocular
lens (iol), nicked, chipped
lens (iol), scratch, mark on
lens (iol), torn, split, cracked
lens damaged in delivery system
lens replacement
lens stuck in delivery system
lens washers, failure of
lens, cloudy
lens, damaged by cartridge
lens, disc
lens, malposition of
lens, opacification of
lens, repositioning of
lens, stuck in cartridge
lens, toric
lens, vaulting
light interference
locking mechanism failure
lockout mechanism failure
looping
loose
loose or intermittent connection
loosening of implant not related to bone-ingrowth
loss of data
loss of or failure to bond
loss of osseointegration
loss of power
loss of threshold
low audible alarm
low battery
low impedance
low ph
low readings
low sensing threshold
low test results
magnet failure
magnetic interference
maintenance does not comply to manufacturers recommendations
malfunction
malposition of device
manufacturing, packaging or shipping problem
markings unclear
markings, none
material deformation
material discolored
material disintegration
material distortion
material erosion
material fragmentation
material frayed
material integrity problem
material invagination
material opacification
material perforation
material protrusion/extrusion
material puncture/hole
material rupture
material separation
material split, cut or torn
material too rigid or stiff
material too soft/flexible
material torqued
material twisted/bent
measurement system incompatibility
measurements, inaccurate
mechanical jam
mechanical problem
mechanics altered
medical gas supply problem
melted
membrane leak(s)
membrane tear(s)
metal shedding debris
method, improper/incorrect
microbial contamination of device
migration
migration or expulsion of device
milliamps (ma) rate, unable to increase
mineralization
misapplication
misassembled
misassembled during installation
misassembly by users
misassembly during maintenance/repair
misconnection
misfire
misfocusing
mislabeled
misplacement
missing information
missing test results
missing value reason
moisture damage
moisture or humidity problem
monitor display alarm, failure of
monitor failure
motion detector failure
motor failure
mushroomed
naturally worn
needle, extra
needle, separation
needle, unsheathed
no apparent adverse event
no audible alarm
no audible prompt/feedback
no device output
no display/image
no fail-safe mechanism
no flow
no pacing
no pressure
no tactile prompts/feedback
no telemetry
no visual prompts/feedback
noise
noise, audible
non reproducible results
non-linear
nonstandard device
normal
obstruction of flow
occlusion within device
occlusion, incorrect
off-label use
old to be deactivated
operating system becomes nonfunctional
operating system version or upgrade problem
optical decentration
optical discoloration
optical distortion
optical obstruction
optical problem
osseointegration problem
other (for use when an appropriate device code cannot be identified)
out-of-box failure
output above specifications
output below specifications
output problem
output, high
output, low
over-sensing
overcorrection
overdelivery
overfill
overheating of device
pacemaker found in back-up mode
pacing asynchronously
pacing inadequately
pacing intermittently
pacing problem
packaging problem
pallet crack(s)
paravalvular leak(s)
partial blockage
particulates
patient data problem
patient device interaction problem
patient-device incompatibility
peeled/delaminated
percutaneous
performance
perivalvular leak
ph, low
phantom problem
physical property issue
physical resistance
physical resistance/sticking
pierce
pipette, failure to aspirate
pitted
plunge
plunger not aligned properly
plunger override
pocket stimulation
poor gas exchange
poor quality image
poor visibility
port leak(s)
positioning failure
positioning problem
potentiometer readings, low
powder leak
power conditioning problem
power problem
pre or post-pumping problem
precipitate in device or device ingredient
premature activation
premature discharge of battery
premature elective replacement indicator
premature end-of-life indicator
premature explantation
premature indicator activation
premature separation
premature system activation
pressure problem
pressure sensor failure
pressure, insufficient
priming problem
probe failure
problem with removal of enzymatic cleaner
problem with software installation
problem with sterilization
product quality problem
program or algorithm execution failure
program or algorithm execution problem
program, failure to
programming issue
protective measures problem
pumping problem
pumping stopped
r on t phenomenon
radiation leak
radiation output failure
radiation output problem
radiation overexposure
radiation overexposure
radiation underexposure
radiation underexposure
radio signal problem
radiofrequency interference (rfi)
reaction
receiver stimulator unit, failure of
reflux within device
repair
replace
reservoir
reset problem
residue after decontamination
resistance, loss of
respirator, detachment from
restricted flow rate
retraction problem
reuse
reverse osmosis
runaway
rupture due to capsulotomy
rupture due to trauma
rupture, cause unknown
safety interlock(s) inadequate
salt tablet(s), use of
scratched material
screw head(s), incorrect
seal, defective
seal, incorrect
sediment filter problems
sediment, precipitate or deposit in device or device ingredient
self-activation or keying
semiautomatic code, failure to override
sensing intermittently
sensor problems
separation failure
separation problem
shaft break
shaft, split
sharp edges
sharp/jagged/rough/etched/scratched
shelf life exceeded
shielding failure
shielding, inadequate
shipping damage or problem
shock, electrical
shock, failure to advise
short fill
shoulder support, detachment of
shutter failure
side rails, failure of
signal artifact/noise
smoking
solder joint fracture
source, detachment from
source, incorrect
source, leak(s) from
sparking
specialty beds, rips/tears in
spillage, accidental
split
spring loading mechanism problem
steering wire problem
sterility
sticking
stopcock valve, failure of
stretched
strikethrough
structural problem
strut fracture
suction failure
suction problem
superheat
surgical graft, failure of
suspect emi
suture line disruption
suture line separation
syringe markings, incorrectly placed
syringe, defective
syringe, hole(s) in
system fails to activate
table collapse
table, tilting
tactile prompts/feedback
tear, rip or hole in device packaging
tears, rips, holes in device, device material
telemetry discrepancy
temperature problem
therapeutic or diagnostic output failure
therapy delivered to incorrect body area
thermal decomposition of device
thickening of material
tidal volume fluctuations
tip breakage
torn material
traditional use
transducer failure
transducer overheating
transducer probe overheating
trocar failure
tube(s), buckling of
tube(s), defective
tube(s), splitting of
unable to confirm conditions of use
unable to obtain readings
unauthorized access to computer system
unclear information
uncoiled
under-sensing
undercorrection
undercorrection
underdelivery
unexpected color
unexpected shutdown
unexpected therapeutic results
unexpected/unintended radiation output
unfold, difficult to
unintended application program shut down
unintended arm motion
unintended collision
unintended compatibility
unintended deflation
unintended ejection
unintended electrical shock
unintended head motion
unintended magnet quench
unintended movement
unintended power up
unintended system motion
unit inactivated
unknown (for use when the device problem is not known)
unraveled material
unsealed device packaging
unstable
unstable capture threshold
unwrap, difficult to
use of device problem
use of incorrect control/treatment settings
vacuum, loss of
valve(s), defective
valve(s), failure of
valve(s), sticking
ventilation problem in device environment
vibration
visual prompts will not clear
volume accuracy problem
water softener regeneration cycle, mistiming of
wedge filter problem
wire(s), breakage of
wireless communication problem
wrinkled
wrong label
year 2000 (y2k) related problem