TPLC - Total Product Life Cycle

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Device	compressor, cardiac, external
Regulation Description	External cardiac compressor.
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	2263	2263
Use of Device Problem	677	677
Failure to Power Up	122	122
Display or Visual Feedback Problem	113	113
Unexpected Shutdown	112	112
Adverse Event Without Identified Device or Use Problem	107	107
Electrical /Electronic Property Problem	77	77
Battery Problem	74	74
No Display/Image	72	72
Noise, Audible	66	66
Display Difficult to Read	63	63
Mechanical Problem	53	53
Material Integrity Problem	51	51
Retraction Problem	36	36
Material Split, Cut or Torn	29	29
Key or Button Unresponsive/not Working	27	27
Break	24	24
Output Problem	22	22
Fitting Problem	20	20
Mechanical Jam	17	17
Device Emits Odor	16	16
Insufficient Information	16	16
Fire	14	14
Power Problem	12	12
Material Twisted/Bent	12	12
Overheating of Device	10	10
Connection Problem	10	10
Erratic or Intermittent Display	10	10
Unexpected Therapeutic Results	9	9
Intermittent Loss of Power	8	8
Patient Device Interaction Problem	8	8
Therapeutic or Diagnostic Output Failure	7	7
Detachment of Device or Device Component	6	6
Complete Loss of Power	6	6
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Difficult to Remove	5	5
Failure to Charge	5	5
Appropriate Term/Code Not Available	5	5
Failure to Eject	4	4
Defective Device	3	3
Sharp Edges	3	3
Activation, Positioning or Separation Problem	3	3
Physical Resistance/Sticking	3	3
Failure to Run on Battery	2	2
Smoking	2	2
Charging Problem	2	2
Application Program Version or Upgrade Problem	2	2
Intermittent Energy Output	2	2
Loss of Power	2	2
Loose or Intermittent Connection	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2778	2778
Insufficient Information	834	834
Cardiac Arrest	46	46
Bone Fracture(s)	24	24
Hemorrhage/Bleeding	22	22
Laceration(s)	18	18
Liver Laceration(s)	14	14
Unspecified Heart Problem	9	9
Skin Tears	9	9
Multiple Fractures	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Bruise/Contusion	4	4
Liver Damage/Dysfunction	3	3
Respiratory Arrest	3	3
Rupture	3	3
Burn(s)	3	3
Pleural Effusion	3	3
Sepsis	2	2
Perforation	2	2
Skin Erosion	2	2
Pulmonary Edema	2	2
Internal Organ Perforation	2	2
Death	1	1
Pneumothorax	1	1
Joint Dislocation	1	1
Spinal Column Injury	1	1
Cardiac Perforation	1	1
Cardiopulmonary Arrest	1	1
Pain	1	1
Scar Tissue	1	1
Renal Impairment	1	1
Asystole	1	1
Vascular System (Circulation), Impaired	1	1
Myocardial Infarction	1	1
Unspecified Respiratory Problem	1	1
Aneurysm	1	1
Loss of consciousness	1	1
Paraplegia	1	1