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Device
system, thermal regulating
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
1
BRAIN COOL AB
SUBSTANTIALLY EQUIVALENT
1
CARE ESSENTIALS PTY LTD
SUBSTANTIALLY EQUIVALENT
1
ENCOMPASS GROUP, LLC
SUBSTANTIALLY EQUIVALENT
1
IOB MEDICAL INC
SUBSTANTIALLY EQUIVALENT
3
MEDIVANCE, INC.
SUBSTANTIALLY EQUIVALENT
1
MOLNLYCKE HEALTH CARE US, LLC
SUBSTANTIALLY EQUIVALENT
1
SMITHS MEDICAL ASD, INC.
SUBSTANTIALLY EQUIVALENT
1
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
STIHLER ELECTRONIC GMBH
SUBSTANTIALLY EQUIVALENT
1
STRYKER MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1517
1517
2019
2294
2294
2020
2546
2546
2021
2689
2689
2022
3226
3226
2023
2287
2287
Device Problems
MDRs with this Device Problem
Events in those MDRs
Defective Component
2602
2602
Insufficient Cooling
2152
2152
Device Sensing Problem
1859
1859
Inaccurate Flow Rate
1342
1342
Temperature Problem
1341
1341
Failure to Pump
1308
1308
Insufficient Heating
1124
1124
Gas/Air Leak
1032
1032
Restricted Flow rate
858
858
Device Displays Incorrect Message
777
777
Decreased Pump Speed
660
660
Circuit Failure
599
599
Pumping Problem
492
492
Failure to Calibrate
425
425
Operating System Becomes Nonfunctional
289
289
Overheating of Device
280
280
Computer Operating System Problem
271
271
Adverse Event Without Identified Device or Use Problem
234
234
Device Alarm System
221
221
Nonstandard Device
220
220
No Flow
201
201
Fluid/Blood Leak
197
197
Display or Visual Feedback Problem
188
188
Infusion or Flow Problem
186
186
Therapeutic or Diagnostic Output Failure
185
185
Improper or Incorrect Procedure or Method
151
151
Device Operates Differently Than Expected
141
141
Defective Device
140
140
Protective Measures Problem
134
134
Insufficient Flow or Under Infusion
120
120
Material Fragmentation
119
119
Use of Device Problem
114
114
Filling Problem
110
110
Power Problem
100
100
Patient-Device Incompatibility
98
98
Insufficient Information
94
94
Break
93
93
Leak/Splash
88
88
No Display/Image
86
86
Computer Software Problem
85
85
Overfill
84
84
Biocompatibility
80
80
Incorrect, Inadequate or Imprecise Result or Readings
79
79
Component Missing
71
71
Appropriate Term/Code Not Available
70
70
Deformation Due to Compressive Stress
68
68
Fitting Problem
68
68
Material Split, Cut or Torn
66
66
Electrical Shorting
57
57
Noise, Audible
55
55
Output Problem
52
52
Improper Flow or Infusion
49
49
Misassembly by Users
49
49
Calibration Problem
46
46
Device Handling Problem
43
43
Material Twisted/Bent
41
41
Failure to Sense
41
41
Excessive Heating
40
40
Patient Device Interaction Problem
38
38
Loss of Power
38
38
Material Separation
36
36
Erratic or Intermittent Display
35
35
Device Dislodged or Dislocated
35
35
Alarm Not Visible
33
33
Fracture
33
33
Failure to Power Up
31
31
Pressure Problem
31
31
Excessive Cooling
27
27
Physical Resistance/Sticking
27
27
Air Leak
27
27
Output below Specifications
26
26
Partial Blockage
25
25
Device Emits Odor
24
24
Electrical /Electronic Property Problem
22
22
Component Misassembled
22
22
Device Inoperable
21
21
Naturally Worn
20
20
Loss of or Failure to Bond
19
19
Unable to Obtain Readings
18
18
Short Fill
17
17
Solder Joint Fracture
17
17
Thermal Decomposition of Device
17
17
Contamination /Decontamination Problem
17
17
Failure of Device to Self-Test
16
16
Suction Problem
15
15
Disconnection
14
14
Loose or Intermittent Connection
14
14
Mechanical Problem
14
14
No Apparent Adverse Event
14
14
Unexpected Shutdown
14
14
Intermittent Loss of Power
13
13
Inadequate Instructions for Healthcare Professional
13
13
Product Quality Problem
12
12
Image Display Error/Artifact
11
11
Crack
11
11
Material Protrusion/Extrusion
11
11
Device Contamination with Chemical or Other Material
10
10
Use of Incorrect Control/Treatment Settings
10
10
Melted
10
10
Inadequate or Insufficient Training
10
10
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7964
7964
No Known Impact Or Consequence To Patient
3684
3684
No Consequences Or Impact To Patient
3305
3305
No Patient Involvement
1961
1961
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
932
932
Alteration In Body Temperature
627
627
Patient Problem/Medical Problem
358
358
Chills
162
162
No Code Available
148
148
No Information
108
108
Inadequate Pain Relief
106
106
Insufficient Information
99
99
Burn(s)
76
76
Shaking/Tremors
72
72
Death
48
48
Hypothermia
43
43
Partial thickness (Second Degree) Burn
41
41
Convulsion/Seizure
36
36
Skin Discoloration
33
33
Seizures
29
29
Fever
28
28
Therapeutic Effects, Unexpected
25
25
Burn, Thermal
25
25
Skin Tears
22
22
Blister
22
22
Pressure Sores
21
21
Unspecified Infection
20
20
Erythema
18
18
Bradycardia
18
18
Discomfort
17
17
Injury
15
15
Alteration in Body Temperature
15
15
Full thickness (Third Degree) Burn
14
14
Paralysis
14
14
Rash
13
13
Skin Irritation
13
13
Low Blood Pressure/ Hypotension
13
13
Superficial (First Degree) Burn
13
13
Skin Inflammation/ Irritation
12
12
Cardiac Arrest
12
12
Sepsis
11
11
Pneumonia
10
10
Bacterial Infection
9
9
Necrosis
7
7
Swelling
7
7
Tissue Damage
7
7
Pain
6
6
Hyperthermia
6
6
Burning Sensation
5
5
Sedation
5
5
Therapeutic Response, Decreased
5
5
Respiratory Failure
5
5
Complaint, Ill-Defined
4
4
Twitching
4
4
Pulmonary Edema
4
4
Respiratory Distress
4
4
High Blood Pressure/ Hypertension
4
4
Hypoxia
4
4
Bruise/Contusion
4
4
Abrasion
3
3
Cardiopulmonary Arrest
3
3
Emotional Changes
3
3
Brain Injury
3
3
Skin Inflammation
3
3
Electric Shock
3
3
Chemical Exposure
2
2
Confusion/ Disorientation
2
2
Tissue Breakdown
2
2
Sweating
2
2
Cardiogenic Shock
2
2
Meningitis
2
2
Unspecified Tissue Injury
2
2
Not Applicable
2
2
Exposure to Body Fluids
2
2
Irritation
2
2
Hemorrhage/Bleeding
2
2
Local Reaction
2
2
Peeling
2
2
Myocardial Infarction
2
2
Scar Tissue
2
2
Urinary Tract Infection
2
2
Tachycardia
2
2
Ventricular Fibrillation
1
1
Ventricular Tachycardia
1
1
Heart Failure
1
1
Seizures, Grand-Mal
1
1
Thrombosis
1
1
Overdose
1
1
Respiratory Distress Syndrome of Newborns
1
1
Staphylococcus Aureus
1
1
Septic Shock
1
1
Shock
1
1
Hemorrhage, Cerebral
1
1
Hypersensitivity/Allergic reaction
1
1
Hematoma
1
1
Hypovolemic Shock
1
1
Ischemia
1
1
Itching Sensation
1
1
Laceration(s)
1
1
Inflammation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
3M Company - Health Care Business
II
Feb-12-2018
2
Bard Medical Division
II
Apr-27-2019
3
Bard Medical Division
II
Jul-24-2018
4
Belmont Instrument Corporation
II
Oct-31-2022
5
C.R. Bard, Inc.
III
Feb-12-2018
6
Care Essentials Pty., Ltd.
II
Mar-03-2020
7
Cincinnati Sub-Zero Products LLC, a Gentherm Company
II
Nov-18-2019
8
Cincinnati Sub-Zero Products LLC, a Gentherm Company
II
Sep-04-2019
9
Medtronic Perfusion Systems
II
Mar-06-2018
10
Pintler Medical LLC
II
Apr-12-2019
11
Stryker Medical Division of Stryker Corporation
II
Oct-24-2018
12
Stryker Medical Division of Stryker Corporation
II
Jan-27-2018
13
Tec Com Gmbh
II
Nov-12-2019
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