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	1326	1326
Material Integrity Problem	733	733
Fluid/Blood Leak	728	728
Use of Device Problem	388	388
Adverse Event Without Identified Device or Use Problem	75	75
Unexpected Shutdown	59	59
Insufficient Cooling	53	53
Temperature Problem	50	50
Failure to Power Up	50	50
Insufficient Heating	35	35
Difficult to Remove	35	35
Difficult to Advance	30	30
Noise, Audible	25	25
No Display/Image	23	23
Power Problem	20	20
Difficult to Insert	15	15
Intermittent Loss of Power	13	13
Mechanical Problem	12	12
Unraveled Material	9	9
Display or Visual Feedback Problem	9	9
Detachment of Device or Device Component	8	8
Difficult to Flush	8	8
Complete Loss of Power	7	7
Leak/Splash	5	5
Display Difficult to Read	5	5
Infusion or Flow Problem	3	3
Retraction Problem	3	3
Loss of Power	3	3
Loose or Intermittent Connection	3	3
Electrical /Electronic Property Problem	2	2
Connection Problem	2	2
Excessive Cooling	2	2
Material Twisted/Bent	2	2
Output Problem	2	2
Material Split, Cut or Torn	2	2
No Audible Prompt/Feedback	2	2
Break	1	1
No Audible Alarm	1	1
Crack	1	1
Unintended Power Up	1	1
Smoking	1	1
Erratic or Intermittent Display	1	1
Material Rupture	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Increased Pump Speed	1	1
Device Emits Odor	1	1
Incorrect Measurement	1	1
Device Dislodged or Dislocated	1	1
Electrical Shorting	1	1
Key or Button Unresponsive/not Working	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1518	1518
Insufficient Information	589	590
No Consequences Or Impact To Patient	451	451
No Patient Involvement	163	163
No Known Impact Or Consequence To Patient	75	76
Thrombosis/Thrombus	41	41
Swelling/ Edema	16	16
Cardiac Arrest	16	16
Hemorrhage/Blood Loss/Bleeding	12	12
Pulmonary Embolism	11	11
Injury	7	7
Infiltration into Tissue	6	6
Thrombus	6	6
Hematoma	5	5
Pneumothorax	5	5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	5
Death	4	4
Thrombosis	4	4
Vessel Or Plaque, Device Embedded In	3	3
Hemothorax	2	2
Obstruction/Occlusion	2	2
Abdominal Pain	2	2
Unspecified Blood or Lymphatic problem	2	2
Failure of Implant	2	2
Fever	2	2
Cardiac Tamponade	2	2
Convulsion/Seizure	1	1
Loss of consciousness	1	1
Sepsis	1	1
Blister	1	1
Bradycardia	1	1
Ecchymosis	1	1
Skin Discoloration	1	1
Hypothermia	1	1
Abrasion	1	1
Myocardial Infarction	1	1
Perforation of Vessels	1	1
Blood Loss	1	1
Stroke/CVA	1	1
Air Embolism	1	1
Pericardial Effusion	1	1
Ventricular Fibrillation	1	1
Inflammation	1	1
Pain	1	1
Sudden Cardiac Death	1	1
Shock	1	1
Brain Injury	1	1
Chemical Exposure	1	1
Foreign Body In Patient	1	1
No Code Available	1	1

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