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	2687	2688
Failure to Pump	2556	2556
Device Sensing Problem	2181	2186
Defective Component	2128	2128
Inaccurate Flow Rate	1893	1893
Gas/Air Leak	1467	1467
Insufficient Heating	1455	1456
Restricted Flow rate	1234	1234
Decreased Pump Speed	1048	1048
Circuit Failure	780	780
Pumping Problem	630	630
Nonstandard Device	528	528
Failure to Calibrate	483	483
Computer Operating System Problem	448	448
Operating System Becomes Nonfunctional	355	355
Overheating of Device	331	331
Fluid/Blood Leak	239	239
Material Fragmentation	216	216
Calibration Problem	200	200
Overfill	186	187
Improper or Incorrect Procedure or Method	176	176
Power Problem	164	164
Use of Device Problem	159	159
Lack of Effect	119	119
Fitting Problem	113	114
Deformation Due to Compressive Stress	111	111
Patient Device Interaction Problem	99	99
Material Split, Cut or Torn	98	98
Temperature Problem	90	90
Alarm Not Visible	90	90
Material Separation	86	86
Insufficient Device Problem Information	84	84
Failure to Sense	83	84
Biocompatibility	81	81
Electrical Shorting	79	79
Computer Software Problem	77	77
Device Handling Problem	76	76
Device Alarm System	73	73
Misassembly by Users	67	67
Component Missing	60	60
Fracture	57	57
Excessive Heating	43	43
Noise, Audible	38	38
Adverse Event Without Identified Device or Use Problem	37	37
Erratic or Intermittent Display	37	41
Component Misassembled	35	35
Partial Blockage	32	32
Material Twisted/Bent	31	31
Loss of or Failure to Bond	30	30
Physical Resistance/Sticking	29	29

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15246	15260
No Consequences Or Impact To Patient	1381	1381
No Known Impact Or Consequence To Patient	1380	1380
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1316	1317
No Patient Involvement	935	935
Chills	199	199
Insufficient Information	126	128
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 Sore/Ulcer	24	24
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
No Information	12	12
Erythema	12	13
Discomfort	12	12
Unspecified Infection	11	11
Pain	11	11
Sepsis	10	10
Necrosis	10	10
Low Blood Pressure/ Hypotension	9	9
Death	8	8
Seizures	8	8
Therapeutic Effects, Unexpected	7	7
Bacterial Infection	6	6
Tissue Breakdown	6	6
Rash	5	6
Sedation	5	5
Electric Shock	5	5
Peeling	5	5
Burn, Thermal	5	5
Burning Sensation	5	5
Skin Irritation	4	4
Localized Skin Lesion	4	4
Ischemia	4	4
Abrasion	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