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	2807	2807
Use of Device Problem	764	764
Failure to Power Up	151	151
Unexpected Shutdown	131	131
Display or Visual Feedback Problem	125	125
Adverse Event Without Identified Device or Use Problem	115	115
No Display/Image	81	81
Display Difficult to Read	70	70
Battery Problem	70	70
Noise, Audible	68	68
Material Integrity Problem	58	58
Mechanical Problem	51	51
Material Split, Cut or Torn	36	36
Retraction Problem	34	34
Electrical /Electronic Property Problem	25	25
Break	24	24
Fitting Problem	23	23
Output Problem	22	22
Power Problem	18	18
Insufficient Information	15	15
Material Twisted/Bent	14	14
Fire	14	14
Patient Device Interaction Problem	12	12
Erratic or Intermittent Display	12	12
Device Emits Odor	10	10
Intermittent Loss of Power	9	9
Overheating of Device	9	9
Unexpected Therapeutic Results	9	9
Therapeutic or Diagnostic Output Failure	8	8
Connection Problem	7	7
Mechanical Jam	6	6
Complete Loss of Power	6	6
Failure to Charge	5	5
Failure to Run on Battery	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Appropriate Term/Code Not Available	5	5
Difficult to Remove	4	4
Failure to Eject	4	4
Detachment of Device or Device Component	4	4
Defective Device	3	3
Physical Resistance/Sticking	3	3
Activation, Positioning or Separation Problem	3	3
Sharp Edges	3	3
Application Program Version or Upgrade Problem	2	2
Smoking	2	2
Intermittent Energy Output	2	2
Loss of Power	2	2
Loose or Intermittent Connection	2	2
Charging Problem	2	2
Premature Discharge of Battery	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2821	2821
Insufficient Information	860	860
No Patient Involvement	292	292
No Consequences Or Impact To Patient	234	234
Cardiac Arrest	43	43
Bone Fracture(s)	28	28
Hemorrhage/Bleeding	23	23
Laceration(s)	20	20
Liver Laceration(s)	18	18
Death	10	10
Unspecified Heart Problem	9	9
Multiple Fractures	9	9
Skin Tears	9	9
Pleural Effusion	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Bruise/Contusion	4	4
Injury	4	4
Internal Organ Perforation	3	3
Pain	3	3
Cardiac Perforation	3	3
Burn(s)	3	3
No Known Impact Or Consequence To Patient	3	3
Rupture	3	3
Abrasion	3	3
Respiratory Arrest	3	3
Liver Damage/Dysfunction	3	3
Skin Erosion	2	2
Cardiopulmonary Arrest	2	2
Pulmonary Edema	2	2
Perforation	2	2
Sepsis	2	2
Spinal Column Injury	1	1
Contusion	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
Loss of consciousness	1	1
Paraplegia	1	1
Joint Dislocation	1	1
Pneumothorax	1	1
Pulmonary Embolism	1	1