TPLC - Total Product Life Cycle

• 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	1

MDR Year	MDR Reports	MDR Events
2018	783	783
2019	706	706
2020	844	844
2021	755	755
2022	730	730

Device Problems	MDRs with this Device Problem	Events in those MDRs
Visual Prompts will not Clear	2497	2497
Use of Device Problem	467	467
Device Displays Incorrect Message	288	288
Device Operational Issue	280	280
Failure to Power Up	164	164
Device Operates Differently Than Expected	94	94
Unexpected Shutdown	83	83
Display or Visual Feedback Problem	80	80
No Display/Image	75	75
Battery Problem	72	72
Adverse Event Without Identified Device or Use Problem	64	64
Display Difficult to Read	53	53
Material Integrity Problem	39	39
Device Issue	33	33
Noise, Audible	31	31
Material Split, Cut or Torn	28	28
Mechanical Problem	22	22
Power Problem	21	21
Retraction Problem	19	19
Low Battery	14	14
Electrical /Electronic Property Problem	13	13
Loss of Power	11	11
Fitting Problem	11	11
Device Stops Intermittently	10	10
Material Twisted/Bent	9	9
Connection Problem	9	9
Break	8	8
Erratic or Intermittent Display	7	7
Device Inoperable	7	7
Physical Resistance/Sticking	7	7
Patient Device Interaction Problem	7	7
Charging Problem	6	6
Failure to Run on Battery	6	6
Fire	6	6
Positioning Failure	5	5
Activation, Positioning or Separation Problem	5	5
Protective Measures Problem	5	5
Therapeutic or Diagnostic Output Failure	5	5
Intermittent Loss of Power	4	4
Failure to Charge	4	4
Overheating of Device	4	4
Loose or Intermittent Connection	3	3
Appropriate Term/Code Not Available	3	3
Complete Loss of Power	3	3
Output Problem	3	3
Mechanical Jam	2	2
Defective Device	2	2
Application Program Version or Upgrade Problem	2	2
Leak/Splash	2	2
Smoking	2	2
Unexpected Therapeutic Results	1	1
Product Quality Problem	1	1
Therapy Delivered to Incorrect Body Area	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Disconnect	1	1
Device Damaged Prior to Use	1	1
Energy Output Problem	1	1
Material Frayed	1	1
Computer Software Problem	1	1
Difficult or Delayed Positioning	1	1
Detachment of Device or Device Component	1	1
Positioning Problem	1	1
Failure to Shut Off	1	1
Inappropriate or Unexpected Reset	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1371	1371
No Patient Involvement	1128	1128
No Consequences Or Impact To Patient	473	473
Insufficient Information	378	378
No Known Impact Or Consequence To Patient	349	349
Death	35	35
Bone Fracture(s)	19	19
Injury	19	19
Heart Failure	18	18
Hemorrhage/Bleeding	14	14
Cardiac Arrest	13	13
Liver Laceration(s)	12	12
Laceration(s)	10	10
Abrasion	6	6
Multiple Fractures	5	5
Contusion	4	4
Pleural Effusion	4	4
Pain	3	3
Rupture	3	3
Cardiac Perforation	2	2
Not Applicable	2	2
No Information	2	2
Perforation	2	2
Pneumothorax	2	2
Pulmonary Embolism	2	2
Bruise/Contusion	2	2
Cardiopulmonary Arrest	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hematoma	1	1
Airway Obstruction	1	1
Internal Organ Perforation	1	1
No Code Available	1	1
Full thickness (Third Degree) Burn	1	1
Tissue Breakdown	1	1
Patient Problem/Medical Problem	1	1
Vascular System (Circulation), Impaired	1	1
Loss of consciousness	1	1
Aortic Dissection	1	1
Excessive Tear Production	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Michigan Instruments, Inc.	III	May-04-2018
2	ZOLL Circulation, Inc.	II	Oct-21-2022