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	2417	2417
Use of Device Problem	743	743
Electrical /Electronic Property Problem	211	211
Failure to Power Up	133	133
Display or Visual Feedback Problem	121	121
Unexpected Shutdown	119	119
Adverse Event Without Identified Device or Use Problem	117	117
Battery Problem	88	88
No Display/Image	83	83
Key or Button Unresponsive/not Working	71	71
Noise, Audible	70	70
Display Difficult to Read	65	65
Mechanical Problem	61	61
Material Integrity Problem	54	54
Retraction Problem	39	39
Mechanical Jam	32	32
Material Split, Cut or Torn	32	32
Output Problem	26	26
Device Emits Odor	24	24
Break	23	23
Fitting Problem	21	21
Insufficient Device Problem Information	18	18
Erratic or Intermittent Display	15	15
Overheating of Device	14	14
Material Twisted/Bent	14	14
Fire	14	14
Power Problem	13	13
Detachment of Device or Device Component	13	13
Intermittent Loss of Power	10	10
Connection Problem	10	10
Patient Device Interaction Problem	9	9
Unexpected Therapeutic Results	9	9
Difficult to Remove	7	7
Complete Loss of Power	6	6
Failure to Charge	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Appropriate Device Problem Term/Code Not Available	5	5
Failure to Eject	4	4
Temperature Problem	3	3
Activation, Positioning or Separation Problem	3	3
Loss of Power	3	3
Failure to Advance	3	3
Sharp Edges	3	3
Physical Resistance/Sticking	3	3
Device Alarm System	3	3
Therapeutic or Diagnostic Output Failure	3	3
Charging Problem	2	2
Activation Problem	2	2
Application Program Version or Upgrade 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	3193	3193
Insufficient Information	908	908
Cardiac Arrest	49	49
Bone Fracture(s)	24	24
Hemorrhage/Blood Loss/Bleeding	23	23
Laceration(s)	18	18
Liver Laceration(s)	14	14
Skin Tears	11	11
Unspecified Heart Problem	9	9
Multiple Fractures	8	8
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	5
Liver Damage/Dysfunction	4	4
Bruise/Contusion	4	4
Internal Organ Perforation	4	4
Respiratory Arrest	3	3
Rupture	3	3
Burn(s)	3	3
Pleural Effusion	3	3
Unspecified Vascular Problem	3	3
Sepsis	2	2
Perforation	2	2
Skin Erosion	2	2
Extravasation	2	2
Pulmonary Edema	2	2
Shock	2	2
Pulmonary Embolism	1	1
Paraplegia	1	1
Loss of consciousness	1	1
Unspecified Respiratory Problem	1	1
Myocardial Infarction	1	1
Aneurysm	1	1
Unspecified Tissue Injury	1	1
Vascular System (Circulation), Impaired	1	1
Asystole	1	1
Renal Impairment	1	1
Scar Tissue	1	1
Pain	1	1
Cardiopulmonary Arrest	1	1
Cardiac Perforation	1	1
Spinal Column Injury	1	1
Brain Injury	1	1
Joint Dislocation	1	1
Pneumothorax	1	1
Death	1	1
Wound Dehiscence	1	1