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	2
ENCOMPASS GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
IOB MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	4
MEDIVANCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
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
1. K202197 Astopad Patient Warming System

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Cooling	2694	2694
Defective Component	2688	2688
Device Sensing Problem	2221	2221
Failure to Pump	1918	1918
Inaccurate Flow Rate	1786	1786
Gas/Air Leak	1451	1451
Insufficient Heating	1442	1442
Restricted Flow rate	1100	1100
Temperature Problem	936	936
Decreased Pump Speed	931	931
Circuit Failure	771	771
Pumping Problem	617	617
Failure to Calibrate	539	539
Device Displays Incorrect Message	499	499
Computer Operating System Problem	375	375
Operating System Becomes Nonfunctional	356	356
Overheating of Device	334	334
Fluid/Blood Leak	245	245
Nonstandard Device	239	239
Device Alarm System	222	222
Material Fragmentation	200	200
Adverse Event Without Identified Device or Use Problem	194	194
Improper or Incorrect Procedure or Method	193	193
Therapeutic or Diagnostic Output Failure	182	182
Infusion or Flow Problem	166	166
Display or Visual Feedback Problem	156	156
Use of Device Problem	152	152
Overfill	143	143
Power Problem	142	142
Calibration Problem	133	133
Protective Measures Problem	132	132
No Flow	130	130
Defective Device	112	112
Lack of Effect	105	105
Fitting Problem	104	104
Deformation Due to Compressive Stress	98	98
Insufficient Flow or Under Infusion	97	97
Material Split, Cut or Torn	93	93
Alarm Not Visible	84	84
Computer Software Problem	83	83
Insufficient Information	82	82
Biocompatibility	82	82
Filling Problem	80	80
Electrical Shorting	79	79
Patient Device Interaction Problem	72	72
Incorrect, Inadequate or Imprecise Result or Readings	70	70
No Display/Image	69	69
Component Missing	68	68
Leak/Splash	66	68
Device Handling Problem	66	66

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	12369	12371
No Known Impact Or Consequence To Patient	2851	2851
No Consequences Or Impact To Patient	2626	2626
No Patient Involvement	1585	1585
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1257	1257
Alteration In Body Temperature	330	330
Patient Problem/Medical Problem	258	258
Chills	206	206
No Code Available	119	119
Insufficient Information	116	116
Inadequate Pain Relief	101	101
Burn(s)	79	79
Shaking/Tremors	55	55
Partial thickness (Second Degree) Burn	51	51
Convulsion/Seizure	46	46
Skin Discoloration	40	40
Death	34	34
Skin Tears	32	32
No Information	32	32
Blister	29	29
Hypothermia	25	25
Pressure Sores	22	22
Full thickness (Third Degree) Burn	21	21
Erythema	20	20
Bradycardia	19	19
Alteration in Body Temperature	18	18
Therapeutic Effects, Unexpected	17	17
Seizures	17	17
Fever	17	17
Unspecified Infection	15	15
Superficial (First Degree) Burn	15	15
Discomfort	15	15
Burn, Thermal	15	15
Skin Inflammation/ Irritation	14	14
Paralysis	14	14
Rash	13	13
Low Blood Pressure/ Hypotension	11	11
Sepsis	10	10
Necrosis	9	9
Skin Irritation	9	9
Cardiac Arrest	7	7
Swelling	6	6
Burning Sensation	6	6
Pain	6	6
Tissue Damage	5	5
Sedation	5	5
Electric Shock	5	5
Respiratory Distress	4	4
Respiratory Failure	4	4
Bacterial Infection	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Augustine Temperature Management, LLC	II	Jan-10-2025
2	Augustine Temperature Management, LLC	II	Dec-18-2024
3	Bard Medical Division	II	Apr-27-2019
4	Belmont Instrument Corporation	II	Oct-31-2022
5	Care Essentials Pty., Ltd.	II	Mar-03-2020
6	Cincinnati Sub-Zero Products LLC, a Gentherm Company	II	Nov-18-2019
7	Cincinnati Sub-Zero Products LLC, a Gentherm Company	II	Sep-04-2019
8	Medivance Inc.	II	Jul-31-2024
9	Medivance Inc.	II	Mar-26-2024
10	Pintler Medical LLC	II	Apr-12-2019
11	Tec Com Gmbh	II	Nov-12-2019