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	2575	2575
Use of Device Problem	653	653
Failure to Power Up	140	140
Unexpected Shutdown	124	124
Adverse Event Without Identified Device or Use Problem	106	106
Display or Visual Feedback Problem	105	105
No Display/Image	75	75
Noise, Audible	58	58
Display Difficult to Read	58	58
Material Integrity Problem	53	53
Battery Problem	50	50
Mechanical Problem	39	39
Material Split, Cut or Torn	31	31
Retraction Problem	26	26
Fitting Problem	21	21
Electrical /Electronic Property Problem	20	20
Break	20	20
Power Problem	16	16
Fire	14	14
Output Problem	14	14
Insufficient Information	14	14
Patient Device Interaction Problem	12	12
Material Twisted/Bent	11	11
Unexpected Therapeutic Results	9	9
Intermittent Loss of Power	8	8
Erratic or Intermittent Display	8	8
Complete Loss of Power	6	6
Device Emits Odor	6	6
Therapeutic or Diagnostic Output Failure	6	6
Appropriate Term/Code Not Available	5	5
Connection Problem	5	5
Failure to Charge	5	5
Detachment of Device or Device Component	4	4
Failure to Run on Battery	4	4
Difficult to Remove	3	3
Sharp Edges	3	3
Failure to Eject	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Defective Device	2	2
Application Program Version or Upgrade Problem	2	2
Intermittent Energy Output	2	2
Physical Resistance/Sticking	2	2
Loose or Intermittent Connection	2	2
Electrical Overstress	1	1
Smoking	1	1
Unintended Ejection	1	1
Device Difficult to Setup or Prepare	1	1
Energy Output Problem	1	1
Device Handling Problem	1	1
Unintended Electrical Shock	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2499	2499
Insufficient Information	755	755
No Patient Involvement	292	292
No Consequences Or Impact To Patient	234	234
Cardiac Arrest	42	42
Bone Fracture(s)	28	28
Hemorrhage/Bleeding	22	22
Laceration(s)	19	19
Liver Laceration(s)	17	17
Death	10	10
Multiple Fractures	9	9
Unspecified Heart Problem	9	9
Pleural Effusion	7	7
Skin Tears	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Injury	4	4
Bruise/Contusion	4	4
Respiratory Arrest	3	3
Abrasion	3	3
Rupture	3	3
No Known Impact Or Consequence To Patient	3	3
Cardiac Perforation	3	3
Pain	3	3
Internal Organ Perforation	3	3
Liver Damage/Dysfunction	2	2
Sepsis	2	2
Perforation	2	2
Burn(s)	2	2
Cardiopulmonary Arrest	2	2
Pulmonary Edema	2	2
Pneumothorax	1	1
Contusion	1	1
Spinal Column Injury	1	1
Scar Tissue	1	1
Renal Impairment	1	1
Vascular System (Circulation), Impaired	1	1
Myocardial Infarction	1	1
Loss of consciousness	1	1
Paraplegia	1	1
Pulmonary Embolism	1	1