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
Gas/Air Leak	3929	3930
Appropriate Term/Code Not Available	3575	3576
Inability to Auto-Fill	2140	2140
Leak/Splash	2079	2079
Break	1429	1429
Battery Problem	1428	1428
Display or Visual Feedback Problem	1237	1237
Optical Problem	1232	1233
Inflation Problem	1070	1070
Failure to Power Up	1002	1002
Unexpected Shutdown	995	995
Incorrect, Inadequate or Imprecise Result or Readings	883	883
Overheating of Device	852	853
Failure to Sense	824	824
Device Alarm System	797	797
Pressure Problem	754	754
Device Contamination with Body Fluid	718	718
Failure to Charge	684	684
Fluid/Blood Leak	629	629
Difficult to Insert	618	618
Device Displays Incorrect Message	611	611
Electrical /Electronic Property Problem	608	608
Erratic or Intermittent Display	574	574
No Display/Image	544	544
Noise, Audible	497	497
Charging Problem	483	483
Power Problem	447	447
No Device Output	433	433
Premature Discharge of Battery	416	416
Connection Problem	388	388
Restricted Flow rate	375	375
Material Integrity Problem	361	361
Failure to Read Input Signal	356	356
Calibration Problem	351	351
Material Deformation	345	345
Pacing Problem	344	344
Output Problem	327	327
Inappropriate Waveform	317	317
Device Sensing Problem	309	309
Pumping Stopped	277	277
Communication or Transmission Problem	276	276
Key or Button Unresponsive/not Working	272	272
Failure to Calibrate	268	268
Obstruction of Flow	253	253
Mechanical Problem	247	247
Material Rupture	242	243
No Apparent Adverse Event	227	227
Image Display Error/Artifact	217	217
Patient Device Interaction Problem	199	199
Retraction Problem	185	185

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	32907	32912
Insufficient Information	4791	4797
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	324	324
No Patient Involvement	287	287
No Consequences Or Impact To Patient	271	271
Low Blood Pressure/ Hypotension	71	71
Cardiac Arrest	69	69
No Known Impact Or Consequence To Patient	53	53
Hemorrhage/Bleeding	36	36
Needle Stick/Puncture	31	31
Failure of Implant	30	31
Myocardial Infarction	26	26
Death	26	26
Tachycardia	22	22
No Information	20	20
Cardiogenic Shock	19	19
Chest Pain	18	18
Foreign Body In Patient	17	17
Thrombosis/Thrombus	15	15
Abdominal Pain	13	13
Heart Failure/Congestive Heart Failure	13	13
Pain	12	12
Vascular Dissection	12	12
Diminished Pulse Pressure	11	11
Ischemia	10	10
Hematoma	10	10
Stroke/CVA	10	10
Pseudoaneurysm	9	9
Ventricular Fibrillation	9	9
Arrhythmia	9	9
Mitral Valve Insufficiency/ Regurgitation	8	8
Tricuspid Valve Insufficiency/ Regurgitation	7	7
Air Embolism	7	7
Loss of consciousness	7	7
Unspecified Heart Problem	7	7
Bradycardia	7	7
Dyspnea	7	7
High Blood Pressure/ Hypertension	6	6
Low Cardiac Output	6	6
Aortic Valve Stenosis	5	5
Unspecified Vascular Problem	5	5
Shock	5	5
Cardiac Tamponade	5	5
Nausea	5	5
Perforation	4	4
Thromboembolism	4	4
Atrial Fibrillation	4	4
Swelling/ Edema	4	4
Confusion/ Disorientation	4	4
Vomiting	4	4