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	2828	2828
Use of Device Problem	777	777
Failure to Power Up	158	158
Unexpected Shutdown	131	131
Display or Visual Feedback Problem	126	126
Adverse Event Without Identified Device or Use Problem	115	115
No Display/Image	81	81
Display Difficult to Read	71	71
Battery Problem	70	70
Noise, Audible	69	69
Material Integrity Problem	58	58
Mechanical Problem	53	53
Material Split, Cut or Torn	36	36
Retraction Problem	34	34
Electrical /Electronic Property Problem	32	32
Break	24	24
Fitting Problem	23	23
Output Problem	23	23
Power Problem	18	18
Insufficient Information	15	15
Fire	14	14
Material Twisted/Bent	14	14
Device Emits Odor	13	13
Erratic or Intermittent Display	12	12
Patient Device Interaction Problem	12	12
Intermittent Loss of Power	9	9
Overheating of Device	9	9
Unexpected Therapeutic Results	9	9
Mechanical Jam	8	8
Connection Problem	8	8
Therapeutic or Diagnostic Output Failure	8	8
Key or Button Unresponsive/not Working	7	7
Complete Loss of Power	6	6
Failure to Run on Battery	5	5
Appropriate Term/Code Not Available	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Failure to Charge	5	5
Difficult to Remove	4	4
Detachment of Device or Device Component	4	4
Failure to Eject	4	4
Sharp Edges	3	3
Defective Device	3	3
Physical Resistance/Sticking	3	3
Activation, Positioning or Separation Problem	3	3
Charging Problem	2	2
Smoking	2	2
Failure to Advance	2	2
Application Program Version or Upgrade Problem	2	2
Intermittent Energy Output	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	2869	2869
Insufficient Information	872	872
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