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	1
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
	SUBSTANTIALLY EQUIVALENT	2
BRAINCOOL AB
	SUBSTANTIALLY EQUIVALENT	1
CARE ESSENTIALS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
HADLEIGH HEALTH TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU TAPPA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
IOB MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDIVANCE, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
MOLNLYCKE HEALTH CARE US, LLC
	SUBSTANTIALLY EQUIVALENT	1
STIHLER ELECTRONIC GMBH
	SUBSTANTIALLY EQUIVALENT	1
THE SURGICAL COMPANY INTERNATIONAL B.V., DOING BUSINESS AS TSC LIFE
	SUBSTANTIALLY EQUIVALENT	1
XODUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Cooling	2460	2461
Failure to Pump	2322	2322
Device Sensing Problem	2013	2018
Defective Component	1701	1701
Inaccurate Flow Rate	1697	1697
Gas/Air Leak	1424	1424
Insufficient Heating	1331	1332
Restricted Flow rate	1135	1135
Decreased Pump Speed	917	917
Circuit Failure	710	710
Pumping Problem	576	576
Nonstandard Device	565	565
Failure to Calibrate	453	453
Computer Operating System Problem	403	403
Operating System Becomes Nonfunctional	327	327
Overheating of Device	322	322
Calibration Problem	214	214
Fluid/Blood Leak	212	212
Material Fragmentation	203	203
Overfill	183	184
Improper or Incorrect Procedure or Method	161	161
Power Problem	153	153
Use of Device Problem	142	142
Lack of Effect	119	119
Patient Device Interaction Problem	117	117
Deformation Due to Compressive Stress	110	110
Fitting Problem	109	110
Material Split, Cut or Torn	95	95
Failure to Sense	86	87
Material Separation	85	85
Alarm Not Visible	85	85
Insufficient Device Problem Information	78	78
Computer Software Problem	77	77
Device Handling Problem	75	75
Temperature Problem	73	73
Electrical Shorting	62	62
Misassembly by Users	60	60
Component Missing	60	60
Device Alarm System	59	59
Fracture	57	57
Noise, Audible	40	40
Biocompatibility	39	39
Adverse Event Without Identified Device or Use Problem	37	37
Excessive Heating	37	37
Erratic or Intermittent Display	37	41
Component Misassembled	36	36
Loss of or Failure to Bond	31	31
Material Twisted/Bent	30	30
Partial Blockage	30	30
Physical Resistance/Sticking	29	29

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14834	14848
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1210	1211
No Consequences Or Impact To Patient	219	219
Chills	192	192
No Patient Involvement	114	114
Burn(s)	80	80
Insufficient Information	64	66
Convulsion/Seizure	46	46
No Code Available	39	39
Blister	37	37
Partial thickness (Second Degree) Burn	36	38
Skin Discoloration	36	36
Skin Tears	32	32
No Known Impact Or Consequence To Patient	29	29
Pressure Sore/Ulcer	25	25
Skin Inflammation/ Irritation	18	18
Bradycardia	15	15
Superficial (First Degree) Burn	14	14
Full thickness (Third Degree) Burn	13	13
Erythema	12	13
Pain	11	11
Alteration in Body Temperature	11	11
Fever	11	11
Discomfort	10	10
Paralysis	10	10
Necrosis	10	10
Unspecified Infection	9	9
Electrolyte Imbalance	7	7
Low Blood Pressure/ Hypotension	7	7
Sepsis	6	6
Bacterial Infection	6	6
Abrasion	5	5
Local Reaction	5	5
Burning Sensation	5	5
Scar Tissue	5	5
Peeling	5	5
Ischemia	4	4
Localized Skin Lesion	4	4
Unspecified Tissue Injury	4	4
Tissue Breakdown	4	4
Rash	4	5
Electric Shock	4	4
Swelling/ Edema	3	3
Bone Fracture(s)	3	3
Bruise/Contusion	3	3
Caustic/Chemical Burns	3	3
Failure of Implant	3	3
Tachycardia	2	2
Sedation	2	2
Hyperthermia	2	2

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	Gentherm Medical, LLC	II	Aug-14-2026
8	Medivance Inc.	II	Jul-31-2024
9	Medivance Inc.	II	Mar-26-2024