TPLC - Total Product Life Cycle

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Device	system, thermal regulating
Regulation Description	Thermal regulating system.
Definition	If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product Code	DWJ
Regulation Number	870.5900
Device Class	2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	2
AUGUSTINE TEMPERATURE MANAGEMENT
	SUBSTANTIALLY EQUIVALENT	2
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
	SUBSTANTIALLY EQUIVALENT	2
BRAINCOOL AB
	SUBSTANTIALLY EQUIVALENT	1
CARE ESSENTIALS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ENCOMPASS GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
HADLEIGH HEALTH TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU TAPPA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IOB MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDIVANCE, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
MOLNLYCKE HEALTH CARE US, LLC
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STIHLER ELECTRONIC GMBH
	SUBSTANTIALLY EQUIVALENT	1
XODUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Cooling	2804	2805
Failure to Pump	2510	2510
Device Sensing Problem	2292	2298
Defective Component	2165	2165
Inaccurate Flow Rate	1915	1915
Gas/Air Leak	1496	1496
Insufficient Heating	1485	1486
Restricted Flow rate	1236	1236
Decreased Pump Speed	1045	1045
Circuit Failure	782	782
Pumping Problem	643	643
Failure to Calibrate	522	522
Nonstandard Device	494	494
Temperature Problem	489	491
Computer Operating System Problem	461	461
Operating System Becomes Nonfunctional	355	355
Overheating of Device	353	353
Fluid/Blood Leak	260	260
Device Displays Incorrect Message	240	240
Material Fragmentation	217	217
Calibration Problem	211	211
Improper or Incorrect Procedure or Method	187	187
Overfill	186	187
Power Problem	164	164
Use of Device Problem	158	158
Device Alarm System	146	146
Therapeutic or Diagnostic Output Failure	119	120
Lack of Effect	118	118
Adverse Event Without Identified Device or Use Problem	114	115
Infusion or Flow Problem	114	114
Fitting Problem	113	114
Deformation Due to Compressive Stress	112	112
Material Split, Cut or Torn	104	104
Patient Device Interaction Problem	101	101
Alarm Not Visible	90	90
Material Separation	88	88
Insufficient Information	86	86
Display or Visual Feedback Problem	83	84
Biocompatibility	83	83
Computer Software Problem	82	82
Electrical Shorting	79	79
Failure to Sense	79	80
Device Handling Problem	76	76
Component Missing	70	70
Misassembly by Users	67	67
No Flow	66	66
Insufficient Flow or Under Infusion	59	59
Fracture	57	57
Filling Problem	52	52
Noise, Audible	52	52

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15142	15156
No Consequences Or Impact To Patient	1381	1381
No Known Impact Or Consequence To Patient	1380	1380
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1314	1315
No Patient Involvement	935	935
Chills	199	199
Insufficient Information	124	126
No Code Available	106	106
Burn(s)	91	91
Patient Problem/Medical Problem	88	88
Alteration In Body Temperature	77	77
Inadequate Pain Relief	51	51
Convulsion/Seizure	48	48
Skin Discoloration	45	45
Partial thickness (Second Degree) Burn	43	45
Blister	39	39
Skin Tears	35	35
Shaking/Tremors	27	27
Pressure Sores	23	23
Alteration in Body Temperature	20	20
Fever	19	19
Bradycardia	19	19
Skin Inflammation/ Irritation	17	17
Superficial (First Degree) Burn	15	15
Hypothermia	15	15
Full thickness (Third Degree) Burn	14	14
Paralysis	13	13
Erythema	12	13
Discomfort	12	12
No Information	12	12
Pain	11	11
Unspecified Infection	11	11
Sepsis	10	10
Necrosis	9	9
Low Blood Pressure/ Hypotension	9	9
Seizures	8	8
Death	8	8
Therapeutic Effects, Unexpected	7	7
Bacterial Infection	6	6
Tissue Breakdown	6	6
Sedation	5	5
Burn, Thermal	5	5
Peeling	5	5
Electric Shock	5	5
Rash	5	6
Burning Sensation	5	5
Ischemia	4	4
Abrasion	4	4
Unspecified Tissue Injury	4	4
Localized Skin Lesion	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Augustine Temperature Management, LLC	II	Feb-20-2025
2	Augustine Temperature Management, LLC	II	Feb-14-2025
3	Augustine Temperature Management, LLC	II	Jan-10-2025
4	Augustine Temperature Management, LLC	II	Dec-18-2024
5	Belmont Instrument Corporation	II	Oct-31-2022
6	Belmont Instrument LLC	II	Jun-12-2025
7	Care Essentials Pty., Ltd.	II	Mar-03-2020
8	Medivance Inc.	II	Jul-31-2024
9	Medivance Inc.	II	Mar-26-2024