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	2891	2891
Use of Device Problem	810	810
Failure to Power Up	161	161
Unexpected Shutdown	136	136
Display or Visual Feedback Problem	131	131
Adverse Event Without Identified Device or Use Problem	119	119
Electrical /Electronic Property Problem	104	104
No Display/Image	84	84
Battery Problem	76	76
Display Difficult to Read	73	73
Noise, Audible	71	71
Material Integrity Problem	62	62
Mechanical Problem	59	59
Material Split, Cut or Torn	40	40
Retraction Problem	36	36
Key or Button Unresponsive/not Working	32	32
Break	25	25
Output Problem	25	25
Fitting Problem	24	24
Mechanical Jam	24	24
Power Problem	19	19
Device Emits Odor	17	17
Insufficient Information	16	16
Fire	14	14
Erratic or Intermittent Display	14	14
Material Twisted/Bent	14	14
Intermittent Loss of Power	12	12
Patient Device Interaction Problem	12	12
Overheating of Device	11	11
Connection Problem	10	10
Detachment of Device or Device Component	10	10
Unexpected Therapeutic Results	9	9
Therapeutic or Diagnostic Output Failure	8	8
Complete Loss of Power	6	6
Difficult to Remove	6	6
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Failure to Charge	5	5
Failure to Run on Battery	5	5
Appropriate Term/Code Not Available	5	5
Failure to Eject	4	4
Loss of Power	3	3
Activation, Positioning or Separation Problem	3	3
Physical Resistance/Sticking	3	3
Sharp Edges	3	3
Defective Device	3	3
Application Program Version or Upgrade Problem	2	2
Intermittent Energy Output	2	2
Failure to Advance	2	2
Smoking	2	2
Device Alarm System	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3078	3078
Insufficient Information	902	902
No Patient Involvement	292	292
No Consequences Or Impact To Patient	234	234
Cardiac Arrest	49	49
Bone Fracture(s)	28	28
Hemorrhage/Bleeding	24	24
Liver Laceration(s)	20	20
Laceration(s)	20	20
Death	10	10
Skin Tears	10	10
Multiple Fractures	9	9
Unspecified Heart Problem	9	9
Pleural Effusion	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Bruise/Contusion	4	4
Injury	4	4
Liver Damage/Dysfunction	4	4
Cardiac Perforation	3	3
Burn(s)	3	3
No Known Impact Or Consequence To Patient	3	3
Rupture	3	3
Pain	3	3
Abrasion	3	3
Respiratory Arrest	3	3
Internal Organ Perforation	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
Aneurysm	1	1
Joint Dislocation	1	1
Loss of consciousness	1	1
Paraplegia	1	1
Pulmonary Embolism	1	1
Pneumothorax	1	1