TPLC - Total Product Life Cycle

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Device	compressor, cardiac, external
Product Code	DRM
Regulation Number	870.5200
Device Class	2

Premarket Reviews
Manufacturer	Decision
DEFIBTECH, LLC
	SUBSTANTIALLY EQUIVALENT	1
JOLIFE AB
	SUBSTANTIALLY EQUIVALENT	2
RESUSCITATION INTERNATIONAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZOLL CIRCULATION, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Visual Prompts will not Clear	3905	3905
Device Displays Incorrect Message	1430	1430
Device Operational Issue	832	832
Use of Device Problem	712	712
Device Operates Differently Than Expected	559	559
Failure to Power Up	269	269
Battery Problem	193	193
No Display/Image	173	173
Adverse Event Without Identified Device or Use Problem	163	163
Unexpected Shutdown	125	125
Display or Visual Feedback Problem	122	122
Device Stops Intermittently	117	117
Display Difficult to Read	69	69
Noise, Audible	59	59
Break	59	59
Low Battery	57	57
Material Integrity Problem	57	57
Device Issue	54	54
Device Inoperable	42	42
Mechanical Problem	41	41
Material Split, Cut or Torn	37	37
Loss of Power	35	35
Retraction Problem	33	33
Positioning Failure	31	31
Connection Problem	27	27
Power Problem	27	27
Electrical /Electronic Property Problem	25	25
Fitting Problem	23	23
Activation, Positioning or Separation Problem	22	22
Charging Problem	17	17
Insufficient Information	16	16
Loose or Intermittent Connection	16	16
Erratic or Intermittent Display	15	15
Fire	14	14
Patient Device Interaction Problem	14	14
Failure to Charge	13	13
Material Twisted/Bent	12	12
Therapeutic or Diagnostic Output Failure	9	9
Crack	9	9
Unexpected Therapeutic Results	9	9
Component Missing	8	8
Physical Resistance/Sticking	8	8
Output Problem	8	8
Intermittent Loss of Power	8	8
Protective Measures Problem	6	6
Overheating of Device	6	6
Difficult to Remove	6	6
Failure to Run on Battery	6	6
Complete Loss of Power	6	6
Appropriate Term/Code Not Available	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2256	2256
No Patient Involvement	2073	2073
No Known Impact Or Consequence To Patient	1043	1043
No Consequences Or Impact To Patient	732	732
Insufficient Information	649	649
Cardiac Arrest	87	87
Death	82	82
No Information	44	44
Bone Fracture(s)	44	44
Hemorrhage/Bleeding	31	31
Injury	28	28
Laceration(s)	25	25
Liver Laceration(s)	21	21
Heart Failure	18	18
Unspecified Heart Problem	9	9
Loss of consciousness	9	9
Multiple Fractures	9	9
Abrasion	9	9
Patient Problem/Medical Problem	8	8
Pleural Effusion	7	7
Not Applicable	7	7
Rupture	6	6
Contusion	5	5
Internal Organ Perforation	5	5
Bruise/Contusion	5	5
Sepsis	4	4
Cardiac Perforation	4	4
Pulmonary Embolism	4	4
Pneumothorax	4	4
Cardiopulmonary Arrest	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Pain	4	4
Perforation	3	3
Hematoma	3	3
Respiratory Arrest	3	3
Tissue Damage	3	3
Burn(s)	3	3
Loss Of Pulse	3	3
Dyspnea	3	3
Fall	3	3
Pulmonary Edema	2	2
Electrocution	2	2
Cardiac Tamponade	2	2
Spinal Column Injury	2	2
Respiratory Distress	2	2
Renal Impairment	1	1
Collapse	1	1
Scar Tissue	1	1
Ventricular Fibrillation	1	1
Perforation of Vessels	1	1