TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Reviews
Manufacturer	Decision
DEFIBTECH, LLC
	SUBSTANTIALLY EQUIVALENT	2
JOLIFE AB
	SUBSTANTIALLY EQUIVALENT	3
RESUSCITATION INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
RESUSCITATION INTERNATIONAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZOLL CIRCULATION
	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	3935	3935
Device Displays Incorrect Message	1810	1810
Device Operational Issue	832	832
Use of Device Problem	713	713
Device Operates Differently Than Expected	630	630
Failure to Power Up	304	304
Battery Problem	235	235
No Display/Image	183	183
Adverse Event Without Identified Device or Use Problem	172	172
Device Stops Intermittently	127	127
Unexpected Shutdown	125	125
Display or Visual Feedback Problem	124	124
Device Inoperable	91	91
Break	90	90
Display Difficult to Read	69	69
Noise, Audible	62	62
Loss of Power	61	61
Low Battery	58	58
Material Integrity Problem	57	57
Device Issue	54	54
Mechanical Problem	42	42
Retraction Problem	39	39
Material Split, Cut or Torn	37	37
Fitting Problem	32	32
Connection Problem	32	32
Charging Problem	31	31
Positioning Failure	31	31
Power Problem	30	30
Loose or Intermittent Connection	30	30
Electrical /Electronic Property Problem	25	25
Activation, Positioning or Separation Problem	22	22
Insufficient Information	20	20
Failure to Charge	18	18
Crack	17	17
Component Missing	17	17
Erratic or Intermittent Display	16	16
Device Alarm System	16	16
Material Twisted/Bent	16	16
Fire	14	14
Premature Discharge of Battery	14	14
Patient Device Interaction Problem	14	14
Sticking	14	14
Component Falling	13	13
Defective Device	12	12
Unexpected Therapeutic Results	9	9
Therapeutic or Diagnostic Output Failure	9	9
Intermittent Loss of Power	8	8
Improper or Incorrect Procedure or Method	8	8
Defective Component	8	8
Difficult to Remove	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	2259	2259
No Clinical Signs, Symptoms or Conditions	2256	2256
No Known Impact Or Consequence To Patient	1392	1392
No Consequences Or Impact To Patient	777	777
Insufficient Information	649	649
Death	144	144
Cardiac Arrest	122	122
No Information	50	50
Bone Fracture(s)	45	45
Hemorrhage/Bleeding	32	32
Injury	29	29
Laceration(s)	26	26
Liver Laceration(s)	21	21
Heart Failure	18	18
Loss of consciousness	12	12
Unspecified Heart Problem	9	9
Multiple Fractures	9	9
Abrasion	9	9
Rupture	9	9
Patient Problem/Medical Problem	8	8
Cardiopulmonary Arrest	8	8
Pneumothorax	7	7
Internal Organ Perforation	7	7
Not Applicable	7	7
Pleural Effusion	7	7
Bruise/Contusion	6	6
Tissue Damage	5	5
Contusion	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Pulmonary Embolism	4	4
Respiratory Distress	4	4
Sepsis	4	4
No Code Available	4	4
Pain	4	4
Dyspnea	4	4
Cardiac Perforation	4	4
Myocardial Infarction	3	3
Fall	3	3
Vomiting	3	3
Loss Of Pulse	3	3
Burn(s)	3	3
Perforation	3	3
Hematoma	3	3
Respiratory Arrest	3	3
Ventricular Fibrillation	2	2
Cardiac Tamponade	2	2
Spinal Column Injury	2	2
Electrocution	2	2
Pulmonary Edema	2	2
Respiratory Failure	2	2