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	1038	1038
Fluid/Blood Leak	621	621
Material Integrity Problem	618	618
Use of Device Problem	302	302
Adverse Event Without Identified Device or Use Problem	58	58
Unexpected Shutdown	45	45
Temperature Problem	43	43
Insufficient Cooling	42	42
Failure to Power Up	37	37
Insufficient Heating	29	29
Difficult to Remove	28	28
Difficult to Advance	28	28
Noise, Audible	21	21
No Display/Image	19	19
Difficult to Insert	12	12
Power Problem	11	11
Mechanical Problem	9	9
Unraveled Material	8	8
Intermittent Loss of Power	8	8
Leak/Splash	8	8
Display or Visual Feedback Problem	7	7
Complete Loss of Power	6	6
Material Rupture	6	7
Difficult to Flush	5	5
Infusion or Flow Problem	5	5
Detachment of Device or Device Component	5	5
Break	4	4
Loss of Power	3	3
Display Difficult to Read	3	3
Material Split, Cut or Torn	3	3
Retraction Problem	3	3
Positioning Problem	2	2
Air/Gas in Device	2	2
Crack	2	2
Output Problem	2	2
Backflow	2	3
Excessive Cooling	2	2
Gas/Air Leak	2	2
Improper Flow or Infusion	2	2
Material Twisted/Bent	2	2
Electrical /Electronic Property Problem	1	1
Failure to Deflate	1	1
Connection Problem	1	1
Loose or Intermittent Connection	1	1
Excessive Heating	1	1
Device Dislodged or Dislocated	1	1
Erratic or Intermittent Display	1	1
Electrical Shorting	1	1
Tear, Rip or Hole in Device Packaging	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1406	1406
Insufficient Information	540	541
No Consequences Or Impact To Patient	205	205
No Patient Involvement	63	63
Thrombosis/Thrombus	35	35
Cardiac Arrest	15	15
Swelling/ Edema	13	13
Hemorrhage/Bleeding	11	11
Pulmonary Embolism	9	9
Infiltration into Tissue	5	5
Pneumothorax	5	5
Hematoma	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Injury	3	3
No Known Impact Or Consequence To Patient	3	3
Cardiac Tamponade	2	2
Obstruction/Occlusion	2	2
Unspecified Blood or Lymphatic problem	2	2
Fever	2	2
Failure of Implant	2	2
Death	2	2
Hemothorax	2	2
Abdominal Pain	2	2
Pericardial Effusion	1	1
Blister	1	1
Abrasion	1	1
Skin Discoloration	1	1
Inflammation	1	1
Brain Injury	1	1
Ventricular Fibrillation	1	1
Foreign Body In Patient	1	1
Sepsis	1	1
Ecchymosis	1	1
Hypothermia	1	1
Pain	1	1
Bradycardia	1	1
Stroke/CVA	1	1
Shock	1	1
Perforation of Vessels	1	1
Sudden Cardiac Death	1	1
Myocardial Infarction	1	1
Convulsion/Seizure	1	1
Air Embolism	1	1
Vessel Or Plaque, Device Embedded In	1	1
Loss of consciousness	1	1
Heart Block	1	1
Thrombus	1	1

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