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	1
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
XODUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Cooling	2379	2380
Failure to Pump	2110	2110
Device Sensing Problem	1917	1923
Defective Component	1702	1702
Inaccurate Flow Rate	1604	1604
Gas/Air Leak	1410	1410
Insufficient Heating	1304	1305
Restricted Flow rate	1060	1060
Decreased Pump Speed	898	898
Circuit Failure	694	694
Pumping Problem	557	557
Failure to Calibrate	455	455
Nonstandard Device	436	436
Computer Operating System Problem	397	397
Operating System Becomes Nonfunctional	327	327
Overheating of Device	298	298
Fluid/Blood Leak	213	213
Material Fragmentation	203	203
Overfill	179	180
Calibration Problem	174	174
Improper or Incorrect Procedure or Method	158	158
Power Problem	150	150
Use of Device Problem	132	132
Lack of Effect	117	117
Fitting Problem	107	108
Deformation Due to Compressive Stress	105	105
Patient Device Interaction Problem	98	98
Material Split, Cut or Torn	93	93
Temperature Problem	87	89
Alarm Not Visible	85	85
Material Separation	80	80
Computer Software Problem	76	76
Device Handling Problem	75	75
Insufficient Information	74	74
Failure to Sense	71	72
Component Missing	61	61
Misassembly by Users	59	59
Electrical Shorting	58	58
Device Alarm System	57	57
Fracture	56	56
Adverse Event Without Identified Device or Use Problem	45	46
Biocompatibility	41	41
Noise, Audible	39	39
Excessive Heating	37	37
Erratic or Intermittent Display	36	40
Component Misassembled	33	33
Physical Resistance/Sticking	31	31
Partial Blockage	30	30
Material Twisted/Bent	30	30
Loss of or Failure to Bond	28	28

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14172	14186
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1204	1205
No Consequences Or Impact To Patient	219	219
Chills	186	186
No Patient Involvement	114	114
Burn(s)	77	77
Insufficient Information	54	56
Convulsion/Seizure	46	46
No Code Available	39	39
Blister	36	36
Skin Discoloration	36	36
Partial thickness (Second Degree) Burn	33	35
No Known Impact Or Consequence To Patient	29	29
Skin Tears	28	28
Pressure Sores	20	20
Bradycardia	15	15
Skin Inflammation/ Irritation	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
Discomfort	10	10
Fever	10	10
Paralysis	10	10
Unspecified Infection	8	8
Low Blood Pressure/ Hypotension	7	7
Necrosis	7	7
Bacterial Infection	6	6
Sepsis	6	6
Peeling	5	5
Burning Sensation	5	5
Tissue Breakdown	4	4
Unspecified Tissue Injury	4	4
Scar Tissue	4	4
Rash	4	5
Localized Skin Lesion	4	4
Ischemia	4	4
Electric Shock	4	4
Bruise/Contusion	3	3
Abrasion	3	3
Bone Fracture(s)	3	3
Caustic/Chemical Burns	3	3
Swelling/ Edema	3	3
Failure of Implant	3	3
Skin Burning Sensation	2	2
Post Operative Wound Infection	2	2
Chemical Exposure	2	2
Skin Infection	2	2
Hemorrhage/Bleeding	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	Medivance Inc.	II	Jul-31-2024
8	Medivance Inc.	II	Mar-26-2024