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	2835	2835
Gas/Air Leak	2163	2163
Leak/Splash	1766	1766
Inability to Auto-Fill	1615	1615
Optical Problem	1289	1289
Break	1215	1215
Battery Problem	1201	1201
Failure to Sense	940	940
Incorrect, Inadequate or Imprecise Result or Readings	915	915
Display or Visual Feedback Problem	893	893
Unexpected Shutdown	852	852
Inflation Problem	790	790
Failure to Power Up	784	784
Pressure Problem	693	693
Failure to Charge	653	653
Device Displays Incorrect Message	612	612
Difficult to Insert	571	571
Erratic or Intermittent Display	562	562
Overheating of Device	556	556
No Display/Image	547	547
Device Contamination with Body Fluid	543	543
Premature Discharge of Battery	474	474
Device Alarm System	449	449
Fluid/Blood Leak	440	440
Noise, Audible	409	409
Power Problem	396	396
Connection Problem	311	311
Calibration Problem	305	305
Material Deformation	295	295
Electrical /Electronic Property Problem	292	292
Pumping Stopped	269	269
Inappropriate Waveform	261	261
Communication or Transmission Problem	253	253
Material Integrity Problem	243	243
Output Problem	240	240
Charging Problem	204	204
Retraction Problem	185	185
Material Rupture	178	178
Mechanical Problem	174	174
Difficult to Advance	168	168
No Apparent Adverse Event	167	167
No Device Output	162	162
Device Contamination with Chemical or Other Material	157	157
Decrease in Suction	143	143
Failure to Zero	139	139
Failure to Calibrate	139	139
Backflow	139	139
Restricted Flow rate	126	126
Mechanical Jam	106	106
Inadequate User Interface	105	105

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	23224	23225
Insufficient Information	4187	4187
No Consequences Or Impact To Patient	1837	1837
No Patient Involvement	1656	1656
No Known Impact Or Consequence To Patient	519	519
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	306	306
Death	101	101
Low Blood Pressure/ Hypotension	65	65
Cardiac Arrest	59	59
Needle Stick/Puncture	47	47
No Information	41	41
Hemorrhage/Bleeding	31	31
Failure of Implant	27	27
Injury	26	26
Tachycardia	24	24
Myocardial Infarction	19	19
Cardiogenic Shock	19	19
Pain	15	15
Chest Pain	15	15
Vascular Dissection	14	14
Abdominal Pain	13	13
Stroke/CVA	13	13
Thrombosis/Thrombus	12	12
Foreign Body In Patient	12	12
Arrhythmia	11	11
Hematoma	11	11
Ischemia	10	10
Diminished Pulse Pressure	10	10
Bradycardia	9	9
Ventricular Fibrillation	9	9
Heart Failure/Congestive Heart Failure	8	8
Low Cardiac Output	8	8
Air Embolism	8	8
Pseudoaneurysm	7	7
Dyspnea	6	6
High Blood Pressure/ Hypertension	6	6
Perforation	6	6
Fever	5	5
Calcium Deposits/Calcification	5	5
Cardiac Tamponade	5	5
Shock	5	5
Unspecified Vascular Problem	5	5
Nausea	5	5
Atrial Fibrillation	4	4
Thromboembolism	4	4
Confusion/ Disorientation	4	4
Thrombus	4	4
Low Oxygen Saturation	4	4
Unspecified Heart Problem	3	3
Cardiovascular Insufficiency	3	3