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	907	907
Fluid/Blood Leak	556	556
Material Integrity Problem	554	554
Use of Device Problem	272	272
Adverse Event Without Identified Device or Use Problem	59	59
Unexpected Shutdown	41	41
Temperature Problem	36	36
Insufficient Cooling	33	33
Difficult to Remove	27	27
Difficult to Advance	25	25
Insufficient Heating	22	22
Failure to Power Up	22	22
Noise, Audible	19	19
No Display/Image	15	15
Difficult to Insert	11	11
Leak/Splash	10	10
Power Problem	9	9
Complete Loss of Power	6	6
Intermittent Loss of Power	6	6
Material Rupture	6	7
Unraveled Material	6	6
Display or Visual Feedback Problem	6	6
Mechanical Problem	6	6
Difficult to Flush	4	4
Detachment of Device or Device Component	4	4
Infusion or Flow Problem	4	4
Material Split, Cut or Torn	3	3
Improper Flow or Infusion	3	3
Loss of Power	3	3
Display Difficult to Read	3	3
Break	3	3
Crack	2	2
Loose or Intermittent Connection	2	2
Backflow	2	3
Gas/Air Leak	2	2
Output Problem	2	2
Positioning Problem	2	2
Connection Problem	2	2
Air/Gas in Device	2	2
Key or Button Unresponsive/not Working	1	1
Pumping Problem	1	1
Excessive Heating	1	1
Incomplete or Inadequate Connection	1	1
Failure to Deflate	1	1
Material Separation	1	1
Smoking	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Material Twisted/Bent	1	1
Device Dislodged or Dislocated	1	1
Excessive Cooling	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1399	1399
Insufficient Information	546	547
Thrombosis/Thrombus	38	38
Cardiac Arrest	16	16
Swelling/ Edema	15	15
Hemorrhage/Bleeding	11	11
Pulmonary Embolism	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Infiltration into Tissue	5	5
Hematoma	4	4
Pneumothorax	3	3
Abdominal Pain	2	2
Failure of Implant	2	2
Obstruction/Occlusion	2	2
Cardiac Tamponade	2	2
Unspecified Blood or Lymphatic problem	2	2
Fever	2	2
Air Embolism	1	1
Stroke/CVA	1	1
Sepsis	1	1
Brain Injury	1	1
Inflammation	1	1
Pericardial Effusion	1	1
Blister	1	1
Skin Discoloration	1	1
Foreign Body In Patient	1	1
Ecchymosis	1	1
Hypothermia	1	1
Pain	1	1
Bradycardia	1	1
Shock	1	1
Perforation of Vessels	1	1
Myocardial Infarction	1	1
Convulsion/Seizure	1	1
Heart Block	1	1
Hemothorax	1	1

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