TPLC - Total Product Life Cycle

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Device	system, balloon, intra-aortic and control
Regulation Description	Intra-aortic balloon and control system.
Product Code	DSP
Regulation Number	870.3535
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	3133	3134
Gas/Air Leak	2749	2749
Leak/Splash	1813	1813
Inability to Auto-Fill	1812	1812
Battery Problem	1301	1301
Break	1299	1299
Optical Problem	1231	1232
Display or Visual Feedback Problem	1114	1114
Inflation Problem	915	915
Failure to Power Up	902	902
Unexpected Shutdown	874	874
Incorrect, Inadequate or Imprecise Result or Readings	871	871
Failure to Sense	807	807
Overheating of Device	760	761
Device Alarm System	669	669
Failure to Charge	656	656
Pressure Problem	643	643
Device Contamination with Body Fluid	631	631
Device Displays Incorrect Message	611	611
Difficult to Insert	565	565
Erratic or Intermittent Display	539	539
Fluid/Blood Leak	525	525
No Display/Image	519	519
Electrical /Electronic Property Problem	484	484
Noise, Audible	446	446
Power Problem	411	411
Premature Discharge of Battery	409	409
Connection Problem	346	346
No Device Output	322	322
Output Problem	314	314
Calibration Problem	310	310
Charging Problem	308	308
Material Integrity Problem	308	308
Material Deformation	289	289
Inappropriate Waveform	284	284
Pumping Stopped	243	243
Communication or Transmission Problem	240	240
Failure to Read Input Signal	217	217
Mechanical Problem	208	208
No Apparent Adverse Event	194	194
Device Sensing Problem	184	184
Retraction Problem	183	183
Patient Device Interaction Problem	180	180
Restricted Flow rate	178	178
Material Rupture	177	178
Key or Button Unresponsive/not Working	170	170
Failure to Calibrate	167	167
Difficult to Advance	152	152
Decrease in Suction	148	148
Insufficient Information	139	139

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	28561	28565
Insufficient Information	4662	4668
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	314	314
No Patient Involvement	287	287
No Consequences Or Impact To Patient	271	271
Low Blood Pressure/ Hypotension	64	64
Cardiac Arrest	61	61
No Known Impact Or Consequence To Patient	53	53
Needle Stick/Puncture	31	31
Hemorrhage/Bleeding	30	30
Failure of Implant	30	31
Death	26	26
Myocardial Infarction	24	24
Tachycardia	22	22
No Information	20	20
Cardiogenic Shock	19	19
Chest Pain	18	18
Thrombosis/Thrombus	14	14
Abdominal Pain	13	13
Heart Failure/Congestive Heart Failure	13	13
Foreign Body In Patient	12	12
Vascular Dissection	12	12
Pain	12	12
Stroke/CVA	10	10
Hematoma	10	10
Ischemia	10	10
Diminished Pulse Pressure	10	10
Ventricular Fibrillation	9	9
Arrhythmia	9	9
Pseudoaneurysm	9	9
Air Embolism	7	7
Dyspnea	7	7
Bradycardia	7	7
Low Cardiac Output	6	6
High Blood Pressure/ Hypertension	6	6
Nausea	5	5
Cardiac Tamponade	5	5
Unspecified Vascular Problem	5	5
Perforation	4	4
Shock	4	4
Atrial Fibrillation	4	4
Mitral Valve Insufficiency/ Regurgitation	4	4
Vomiting	4	4
Confusion/ Disorientation	4	4
Thromboembolism	4	4
Cardiomyopathy	3	3
Calcium Deposits/Calcification	3	3
Lactate Dehydrogenase Increased	3	3
Unspecified Kidney or Urinary Problem	3	3
Paresis	3	3