TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Visual Prompts will not Clear	2722	2722
Use of Device Problem	608	608
Failure to Power Up	151	151
Unexpected Shutdown	118	118
Adverse Event Without Identified Device or Use Problem	102	102
Display or Visual Feedback Problem	102	102
No Display/Image	74	74
Display Difficult to Read	61	61
Material Integrity Problem	56	56
Noise, Audible	43	43
Mechanical Problem	39	39
Battery Problem	38	38
Material Split, Cut or Torn	37	37
Electrical /Electronic Property Problem	25	25
Power Problem	23	23
Retraction Problem	22	22
Break	18	18
Fitting Problem	17	17
Fire	14	14
Patient Device Interaction Problem	14	14
Material Twisted/Bent	10	10
Erratic or Intermittent Display	9	9
Unexpected Therapeutic Results	9	9
Physical Resistance/Sticking	8	8
Intermittent Loss of Power	8	8
Therapeutic or Diagnostic Output Failure	7	7
Output Problem	6	6
Connection Problem	6	6
Complete Loss of Power	5	5
Insufficient Information	4	4
Appropriate Term/Code Not Available	4	4
Failure to Run on Battery	4	4
Defective Device	3	3
Application Program Version or Upgrade Problem	2	2
Detachment of Device or Device Component	2	2
Smoking	2	2
Leak/Splash	2	2
Loose or Intermittent Connection	2	2
Failure to Charge	2	2
Mechanical Jam	2	2
Intermittent Energy Output	2	2
Positioning Problem	1	1
Protective Measures Problem	1	1
Computer Software Problem	1	1
Material Frayed	1	1
Energy Output Problem	1	1
Overheating of Device	1	1
Loss of Power	1	1
Device Difficult to Setup or Prepare	1	1
Product Quality Problem	1	1
Device Damaged Prior to Use	1	1
Electrical Overstress	1	1
Inappropriate or Unexpected Reset	1	1
Charging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2061	2061
No Patient Involvement	710	710
Insufficient Information	595	595
No Consequences Or Impact To Patient	438	438
No Known Impact Or Consequence To Patient	59	59
Cardiac Arrest	37	37
Bone Fracture(s)	25	25
Hemorrhage/Bleeding	21	21
Death	19	19
Laceration(s)	18	18
Liver Laceration(s)	17	17
Injury	15	15
Multiple Fractures	9	9
Unspecified Heart Problem	8	8
Pleural Effusion	7	7
Abrasion	5	5
Bruise/Contusion	4	4
Pain	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Respiratory Arrest	3	3
Rupture	3	3
Cardiac Perforation	3	3
Contusion	3	3
Internal Organ Perforation	3	3
Cardiopulmonary Arrest	2	2
Burn(s)	2	2
Perforation	2	2
Sepsis	2	2
Pneumothorax	1	1
Loss of consciousness	1	1
Paraplegia	1	1
Aortic Dissection	1	1
Vascular System (Circulation), Impaired	1	1
Full thickness (Third Degree) Burn	1	1
No Code Available	1	1
Tissue Breakdown	1	1
Airway Obstruction	1	1
Pulmonary Embolism	1	1
Myocardial Infarction	1	1
Liver Damage/Dysfunction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ZOLL Circulation, Inc.	II	Oct-21-2022