TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
FINK ENGINEERING PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K240569 FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Ch ...
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
Use of Device Problem	9	9
Protective Measures Problem	4	4
Fail-Safe Did Not Operate	4	4
Key or Button Unresponsive/not Working	4	4
Improper or Incorrect Procedure or Method	3	3
No Apparent Adverse Event	3	3
Insufficient Information	3	3
Decrease in Pressure	3	3
Air/Gas in Device	2	2
Mechanical Problem	2	2
Fire	2	2
Failure to Align	2	2
Fail-Safe Problem	2	2
Gas/Air Leak	2	2
Unexpected Therapeutic Results	1	1
Pressure Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Patient Device Interaction Problem	1	1
Explosion	1	1
Sharp Edges	1	1
Activation Problem	1	1
Increase in Pressure	1	1
Product Quality Problem	1	1
Burst Container or Vessel	1	1
Complete Blockage	1	1
Crack	1	1
Material Discolored	1	1
Electrical /Electronic Property Problem	1	1
Emergency Power Failure	1	1
Defective Device	1	1
Contamination /Decontamination Problem	1	1
Activation, Positioning or Separation Problem	1	1
Improper Flow or Infusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	40	40
Insufficient Information	6	6
Convulsion/Seizure	5	5
Cramp(s) /Muscle Spasm(s)	2	2
Dyspnea	2	2
Unspecified Tissue Injury	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Total Hearing Loss	1	1
Superficial (First Degree) Burn	1	1
Pneumothorax	1	1
Memory Loss/Impairment	1	1
Transient Ischemic Attack	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Burn(s)	1	1
Partial thickness (Second Degree) Burn	1	1
Headache	1	1
Loss of consciousness	1	1
Neuralgia	1	1