TPLC - Total Product Life Cycle

show TPLC since

Device	compressor, cardiac, external
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	2861	2861
Use of Device Problem	661	661
Failure to Power Up	156	156
Unexpected Shutdown	124	124
Adverse Event Without Identified Device or Use Problem	117	117
Display or Visual Feedback Problem	110	110
No Display/Image	79	79
Display Difficult to Read	68	68
Material Integrity Problem	57	57
Battery Problem	55	55
Noise, Audible	48	48
Mechanical Problem	39	39
Material Split, Cut or Torn	37	37
Electrical /Electronic Property Problem	25	25
Retraction Problem	25	25
Power Problem	23	23
Fitting Problem	21	21
Break	19	19
Patient Device Interaction Problem	14	14
Fire	14	14
Material Twisted/Bent	10	10
Insufficient Information	9	9
Unexpected Therapeutic Results	9	9
Erratic or Intermittent Display	9	9
Intermittent Loss of Power	8	8
Output Problem	8	8
Physical Resistance/Sticking	8	8
Connection Problem	7	7
Therapeutic or Diagnostic Output Failure	7	7
Complete Loss of Power	6	6
Appropriate Term/Code Not Available	4	4
Failure to Run on Battery	4	4
Loose or Intermittent Connection	3	3
Defective Device	3	3
Sharp Edges	2	2
Detachment of Device or Device Component	2	2
Smoking	2	2
Intermittent Energy Output	2	2
Mechanical Jam	2	2
Difficult to Remove	2	2
Application Program Version or Upgrade Problem	2	2
Failure to Charge	2	2
Leak/Splash	2	2
Positioning Problem	1	1
Electrical Overstress	1	1
Product Quality Problem	1	1
Decoupling	1	1
Device Damaged Prior to Use	1	1
Unintended Electrical Shock	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2253	2253
No Patient Involvement	710	710
Insufficient Information	649	649
No Consequences Or Impact To Patient	438	438
No Known Impact Or Consequence To Patient	59	59
Cardiac Arrest	42	42
Bone Fracture(s)	29	29
Hemorrhage/Bleeding	22	22
Laceration(s)	20	20
Death	19	19
Liver Laceration(s)	19	19
Injury	15	15
Unspecified Heart Problem	9	9
Multiple Fractures	9	9
Pleural Effusion	7	7
Abrasion	5	5
Bruise/Contusion	4	4
Pain	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Cardiac Perforation	3	3
Contusion	3	3
Rupture	3	3
Respiratory Arrest	3	3
Internal Organ Perforation	3	3
Burn(s)	2	2
Perforation	2	2
Cardiopulmonary Arrest	2	2
Pulmonary Edema	2	2
Sepsis	2	2
Spinal Column Injury	1	1
Aortic Dissection	1	1
Scar Tissue	1	1
Renal Impairment	1	1
Vascular System (Circulation), Impaired	1	1
Myocardial Infarction	1	1
No Code Available	1	1
Liver Damage/Dysfunction	1	1
Loss of consciousness	1	1
Paraplegia	1	1
Airway Obstruction	1	1
Full thickness (Third Degree) Burn	1	1
Tissue Breakdown	1	1
Pneumothorax	1	1
Pulmonary Embolism	1	1