TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ENVIRONMENTAL TECTONICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
GULF COAST HYPERBARICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
OXAVITA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
OXYHEAL MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
PRESSURE-TECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
REIMERS SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SECHRIST INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
US HYPERBARIC NETWORK
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	12	12
Device Operates Differently Than Expected	7	7
Decrease in Pressure	5	5
Mechanical Problem	4	4
Use of Device Problem	3	3
Burst Container or Vessel	3	3
Break	2	2
Disconnection	2	2
Complete Blockage	2	2
Device Dislodged or Dislocated	2	2
Fail-Safe Problem	2	2
Device Displays Incorrect Message	2	2
Output Problem	2	2
Noise, Audible	2	2
Key or Button Unresponsive/not Working	2	2
Material Split, Cut or Torn	1	1
Sharp Edges	1	1
Fail-Safe Did Not Operate	1	1
Pressure Problem	1	1
Protective Measures Problem	1	1
Torn Material	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Patient-Device Incompatibility	1	1
Contamination /Decontamination Problem	1	1
Activation, Positioning or Separation Problem	1	1
Improper Device Output	1	1
Improper Flow or Infusion	1	1
Mechanics Altered	1	1
Detachment Of Device Component	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Align	1	1
Product Quality Problem	1	1
Material Separation	1	1
Unexpected Therapeutic Results	1	1
Electrical /Electronic Property Problem	1	1
Emergency Power Failure	1	1
Fire	1	1
Gas Output Problem	1	1
Device Alarm System	1	1
Device Reprocessing Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	20	20
No Consequences Or Impact To Patient	8	8
Death	6	6
No Known Impact Or Consequence To Patient	6	6
No Information	3	3
Convulsion/Seizure	3	3
Pain	2	2
Suffocation	2	2
Dyspnea	2	2
Fever	1	1
Headache	1	1
Hepatitis	1	1
Memory Loss/Impairment	1	1
Muscle Spasm(s)	1	1
Myocardial Infarction	1	1
Discomfort	1	1
Fracture, Arm	1	1
Joint Dislocation	1	1
Low Oxygen Saturation	1	1
Sleep Dysfunction	1	1
No Patient Involvement	1	1
Superficial (First Degree) Burn	1	1
Patient Problem/Medical Problem	1	1
Transient Ischemic Attack	1	1
Venipuncture	1	1
Pneumothorax	1	1
No Code Available	1	1
Partial thickness (Second Degree) Burn	1	1
Neuralgia	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Total Hearing Loss	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Cardiopulmonary Arrest	1	1