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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bed, ac-powered adjustable hospital
Regulation Description AC-powered adjustable hospital bed.
Product CodeFNL
Regulation Number 880.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
CARROLL HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 5
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
JOERNS HEALTHCARE INC.
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
M.C. HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
SSC MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
VAIL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Side rails, failure of 2237
Repair 1641
Loose 1603
Slippage of device or device component 655
Sticking 419
Unintended system motion 381
Other (for use when an appropriate device code cannot be identified) 289
Device inoperable 282
Device alarm system issue 267
Unintended head motion 244
Break 241
Mechanical issue 183
Replace 147
Grounding malfunction 140
Electrical issue 91
Tears, rips, holes in device, device material 85
Detachment of device component 76
Moisture damage 71
Device operates differently than expected 66
Contamination during use 61
Insulation degradation 53
No code available 53
Manufacturing or shipping issue associated with device 43
Solder joint failure 42
Unknown (for use when the device problem is not known) 37
Corrosion 28
Arcing 25
Locking mechanism failure 22
No Information 22
Component missing 19
Electrical shorting 18
Naturally worn 17
Loss of power 16
Difficult to position 15
Collapse 14
Cut in material 14
Material separation 13
Component(s), broken 12
Device displays error message 12
Motor failure 11
Bent 11
Failure to power-up 10
Use of Device Issue 10
Unintended movement 10
Entrapment of device or device component 9
Device Issue 9
No Known Device Problem 8
Device stops intermittently 8
No display or display failure 7
Foreign material present in device 6
Positioning Issue 6
Difficult or delayed activation 6
Close, difficult to 5
Device damaged prior to use 5
Malfunction 5
Component falling 5
Device contamination with blood or blood product 5
Smoking 5
Dislodged or dislocated 5
Torn material 5
Spark 5
Foreign material 5
Fracture 5
Hole in material 5
Delayed alarm 4
User used incorrect product for intended use 4
Inadequate training 4
Failure to calibrate 4
Disengaged 4
Burn of device or device component 4
Calibration error 4
Circuit Failure 4
Self-activation or keying 4
Material frayed 3
Device remains activated 3
Misassembled 3
Product quality issue 3
Improper or incorrect procedure or method 3
Power source issue 3
Defective item 3
Device emits odor 3
Migration of device or device component 2
Cable break 2
Device Cleaning Issue 2
Connector pin failure 2
Crack 2
Not audible alarm 2
Overheating of device or device component 2
Detachment of device or device component 2
Defective component 2
Lead(s), breakage of 2
Electronic property issue 2
Failure to service 2
Device maintenance issue 2
Normal 2
Loose or intermittent connection 2
Disconnection 2
Defective Alarm 2
Scratched material 1
Connection issue 1
Total Device Problems 9921

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 3 5 6 2 6 2
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hill-Rom, Inc. II Jun-05-2013
2 Hill-Rom, Inc. II Jun-22-2012
3 Hill-Rom, Inc. II Mar-07-2011
4 Hill-Rom, Inc. II Feb-11-2011
5 Hill-Rom, Inc. II Nov-09-2010
6 Hill-Rom, Inc. II Aug-24-2010
7 Hill-Rom, Inc. II Aug-03-2010
8 Hill-Rom, Inc. II Mar-11-2010
9 Hill-Rom, Inc. II Nov-18-2009
10 Hill-Rom, Inc. II May-01-2009
11 Hill-Rom, Inc. II Jan-16-2009
12 Hill-Rom, Inc. II Sep-05-2008
13 Hill-Rom, Inc. II Aug-27-2008
14 Invacare Corporation II Sep-09-2010
15 KCI USA, Inc. II Sep-27-2012
16 Linet Americas Inc II Jan-13-2012
17 Primus Medical LLC II Nov-08-2012
18 Stryker Medical Div. of Stryker Corporation II Sep-28-2010
19 Stryker Medical Div. of Stryker Corporation II Sep-18-2009
20 Stryker Medical Div. of Stryker Corporation II Feb-25-2009
21 Stryker Medical Div. of Stryker Corporation II Sep-19-2008
22 Stryker Medical Div. of Stryker Corporation II Dec-08-2007
23 Stryker Medical Division of Stryker Corporation II Jan-03-2013
24 Stryker Medical Division of Stryker Corporation II Jun-22-2012
25 Stryker Medical Division of Stryker Corporation II Mar-30-2012

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