TPLC - Total Product Life Cycle

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Device	system, hypothermia, intravenous, cooling
Regulation Description	Thermal regulating system.
Product Code	NCX
Regulation Number	870.5900
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Visual Prompts will not Clear	1085	1085
Fluid/Blood Leak	642	642
Material Integrity Problem	638	638
Use of Device Problem	313	313
Adverse Event Without Identified Device or Use Problem	59	59
Unexpected Shutdown	48	48
Temperature Problem	46	46
Insufficient Cooling	44	44
Failure to Power Up	37	37
Difficult to Remove	31	31
Insufficient Heating	30	30
Difficult to Advance	28	28
Noise, Audible	22	22
No Display/Image	19	19
Difficult to Insert	13	13
Power Problem	12	12
Leak/Splash	11	11
Mechanical Problem	9	9
Intermittent Loss of Power	8	8
Unraveled Material	8	8
Display or Visual Feedback Problem	7	7
Complete Loss of Power	6	6
Material Rupture	6	7
Break	5	5
Difficult to Flush	5	5
Detachment of Device or Device Component	5	5
Infusion or Flow Problem	5	5
Material Split, Cut or Torn	3	3
Loss of Power	3	3
Display Difficult to Read	3	3
Retraction Problem	3	3
Improper Flow or Infusion	3	3
Loose or Intermittent Connection	2	2
Material Twisted/Bent	2	2
Gas/Air Leak	2	2
Backflow	2	3
Air/Gas in Device	2	2
Positioning Problem	2	2
Crack	2	2
Output Problem	2	2
Excessive Cooling	2	2
Key or Button Unresponsive/not Working	1	1
Increased Pump Speed	1	1
Obstruction of Flow	1	1
No Audible Alarm	1	1
Therapeutic or Diagnostic Output Failure	1	1
Inaccurate Flow Rate	1	1
Defective Device	1	1
No Audible Prompt/Feedback	1	1
Defective Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1474	1474
Insufficient Information	566	567
No Consequences Or Impact To Patient	205	205
No Patient Involvement	63	63
Thrombosis/Thrombus	36	36
Cardiac Arrest	15	15
Swelling/ Edema	14	14
Hemorrhage/Bleeding	11	11
Pulmonary Embolism	9	9
Infiltration into Tissue	5	5
Hematoma	5	5
Pneumothorax	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
No Known Impact Or Consequence To Patient	3	3
Injury	3	3
Obstruction/Occlusion	2	2
Failure of Implant	2	2
Hemothorax	2	2
Fever	2	2
Abdominal Pain	2	2
Death	2	2
Cardiac Tamponade	2	2
Unspecified Blood or Lymphatic problem	2	2
Heart Block	1	1
Blister	1	1
Ecchymosis	1	1
Stroke/CVA	1	1
Abrasion	1	1
Air Embolism	1	1
Bradycardia	1	1
Vessel Or Plaque, Device Embedded In	1	1
Hypothermia	1	1
Inflammation	1	1
Myocardial Infarction	1	1
Pain	1	1
Brain Injury	1	1
Sepsis	1	1
Shock	1	1
Skin Discoloration	1	1
Thrombus	1	1
Ventricular Fibrillation	1	1
Perforation of Vessels	1	1
Sudden Cardiac Death	1	1
Loss of consciousness	1	1
Pericardial Effusion	1	1
Convulsion/Seizure	1	1
Foreign Body In Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ZOLL Circulation, Inc.	II	Oct-06-2021