TPLC - Total Product Life Cycle

show TPLC since

Device	system, balloon, intra-aortic and control
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	2635	2635
Gas/Air Leak	1984	1984
Leak/Splash	1681	1681
Inability to Auto-Fill	1519	1519
Optical Problem	1240	1240
Break	1179	1179
Battery Problem	1095	1095
Failure to Sense	911	911
Incorrect, Inadequate or Imprecise Result or Readings	894	894
Unexpected Shutdown	808	808
Display or Visual Feedback Problem	753	753
Failure to Power Up	749	749
Inflation Problem	722	722
Pressure Problem	666	666
Failure to Charge	637	637
Device Displays Incorrect Message	608	608
Erratic or Intermittent Display	553	553
Difficult to Insert	552	552
No Display/Image	533	533
Device Contamination with Body Fluid	532	532
Overheating of Device	491	491
Premature Discharge of Battery	464	464
Fluid/Blood Leak	395	395
Noise, Audible	380	380
Device Alarm System	370	370
Power Problem	370	370
Connection Problem	299	299
Calibration Problem	289	289
Material Deformation	288	288
Pumping Stopped	266	266
Inappropriate Waveform	254	254
Communication or Transmission Problem	239	239
Material Integrity Problem	225	225
Electrical /Electronic Property Problem	212	212
Output Problem	200	200
Charging Problem	194	194
Retraction Problem	180	180
No Apparent Adverse Event	167	167
Difficult to Advance	161	161
No Device Output	158	158
Material Rupture	157	157
Device Contamination with Chemical or Other Material	156	156
Mechanical Problem	146	146
Decrease in Suction	142	142
Backflow	139	139
Failure to Zero	138	138
Failure to Calibrate	122	122
Restricted Flow rate	122	122
Inadequate User Interface	105	105
Adverse Event Without Identified Device or Use Problem	104	104

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	21536	21537
Insufficient Information	3823	3823
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	303	303
Death	101	101
Low Blood Pressure/ Hypotension	62	62
Cardiac Arrest	56	56
Needle Stick/Puncture	47	47
No Information	41	41
Hemorrhage/Bleeding	31	31
Injury	26	26
Failure of Implant	24	24
Tachycardia	23	23
Cardiogenic Shock	18	18
Myocardial Infarction	17	17
Chest Pain	15	15
Vascular Dissection	14	14
Stroke/CVA	13	13
Pain	13	13
Foreign Body In Patient	12	12
Thrombosis/Thrombus	12	12
Abdominal Pain	12	12
Hematoma	11	11
Arrhythmia	10	10
Ischemia	10	10
Diminished Pulse Pressure	10	10
Ventricular Fibrillation	9	9
Bradycardia	8	8
Low Cardiac Output	8	8
Air Embolism	8	8
Pseudoaneurysm	7	7
Heart Failure/Congestive Heart Failure	6	6
Perforation	6	6
High Blood Pressure/ Hypertension	6	6
Dyspnea	6	6
Unspecified Vascular Problem	5	5
Fever	5	5
Cardiac Tamponade	5	5
Shock	5	5
Thromboembolism	4	4
Thrombus	4	4
Low Oxygen Saturation	4	4
Atrial Fibrillation	4	4
Mitral Valve Insufficiency/ Regurgitation	3	3
Laceration(s)	3	3
Paresis	3	3
Unspecified Kidney or Urinary Problem	3	3
Confusion/ Disorientation	3	3