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	942	942
Material Integrity Problem	568	568
Fluid/Blood Leak	562	562
Use of Device Problem	287	287
Adverse Event Without Identified Device or Use Problem	61	61
Unexpected Shutdown	43	43
Insufficient Cooling	38	38
Temperature Problem	36	36
Difficult to Advance	26	26
Difficult to Remove	26	26
Failure to Power Up	26	26
Insufficient Heating	24	24
Noise, Audible	20	20
No Display/Image	17	17
Difficult to Insert	15	15
Power Problem	9	9
Display or Visual Feedback Problem	7	7
Leak/Splash	6	6
Mechanical Problem	6	6
Intermittent Loss of Power	6	6
Complete Loss of Power	6	6
Unraveled Material	6	6
Loss of Power	4	4
Detachment of Device or Device Component	4	4
Difficult to Flush	4	4
Display Difficult to Read	3	3
Loose or Intermittent Connection	3	3
Key or Button Unresponsive/not Working	2	2
Infusion or Flow Problem	2	2
Device Emits Odor	2	2
Connection Problem	2	2
Material Split, Cut or Torn	2	2
High Readings	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Increased Pump Speed	1	1
No Audible Alarm	1	1
Positioning Problem	1	1
Obstruction of Flow	1	1
Material Twisted/Bent	1	1
Smoking	1	1
Material Rupture	1	1
No Audible Prompt/Feedback	1	1
Incorrect Measurement	1	1
Pumping Problem	1	1
Erratic or Intermittent Display	1	1
Device Dislodged or Dislocated	1	1
Excessive Heating	1	1
Unintended Power Up	1	1
Crack	1	1
Failure of Device to Self-Test	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1463	1463
Insufficient Information	567	568
Thrombosis/Thrombus	40	40
Cardiac Arrest	16	16
Swelling/ Edema	15	15
Hemorrhage/Blood Loss/Bleeding	11	11
Pulmonary Embolism	11	11
Infiltration into Tissue	5	5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	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