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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
BRAIN COOL AB
SUBSTANTIALLY EQUIVALENT
1
CARE ESSENTIALS PTY LTD
SUBSTANTIALLY EQUIVALENT
1
ENCOMPASS GROUP, LLC
SUBSTANTIALLY EQUIVALENT
1
IOB MEDICAL INC
SUBSTANTIALLY EQUIVALENT
2
MEDIVANCE, INC.
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
2693
2693
2022
3237
3237
Device Problems
MDRs with this Device Problem
Events in those MDRs
Defective Component
2278
2278
Insufficient Cooling
1818
1818
Device Sensing Problem
1600
1600
Temperature Problem
1328
1328
Inaccurate Flow Rate
1087
1087
Insufficient Heating
930
930
Failure to Pump
911
911
Device Displays Incorrect Message
777
777
Gas/Air Leak
774
774
Restricted Flow rate
705
705
Circuit Failure
495
495
Decreased Pump Speed
434
434
Pumping Problem
384
384
Failure to Calibrate
337
337
Overheating of Device
229
229
Adverse Event Without Identified Device or Use Problem
229
229
Computer Operating System Problem
229
229
Operating System Becomes Nonfunctional
226
226
Device Alarm System
218
218
Nonstandard Device
206
206
No Flow
201
201
Display or Visual Feedback Problem
187
187
Infusion or Flow Problem
185
185
Therapeutic or Diagnostic Output Failure
184
184
Fluid/Blood Leak
163
163
Device Operates Differently Than Expected
141
141
Defective Device
140
140
Protective Measures Problem
134
134
Improper or Incorrect Procedure or Method
129
129
Insufficient Flow or Under Infusion
120
120
Filling Problem
110
110
Use of Device Problem
106
106
Patient-Device Incompatibility
98
98
Break
92
92
Material Fragmentation
91
91
Leak/Splash
88
88
Insufficient Information
86
86
No Display/Image
85
85
Biocompatibility
80
80
Incorrect, Inadequate or Imprecise Result or Readings
79
79
Power Problem
75
75
Computer Software Problem
74
74
Appropriate Term/Code Not Available
70
70
Component Missing
61
61
Overfill
60
60
Fitting Problem
54
54
Output Problem
52
52
Material Split, Cut or Torn
51
51
Noise, Audible
50
50
Improper Flow or Infusion
49
49
Deformation Due to Compressive Stress
47
47
Electrical Shorting
47
47
Calibration Problem
45
45
Misassembly by Users
43
43
Loss of Power
38
38
Material Separation
34
34
Material Twisted/Bent
34
34
Patient Device Interaction Problem
34
34
Device Dislodged or Dislocated
32
32
Erratic or Intermittent Display
32
32
Failure to Sense
31
31
Pressure Problem
31
31
Excessive Heating
30
30
Failure to Power Up
28
28
Air Leak
27
27
Device Handling Problem
26
26
Output below Specifications
26
26
Fracture
25
25
Device Emits Odor
23
23
Excessive Cooling
23
23
Alarm Not Visible
22
22
Device Inoperable
21
21
Loss of or Failure to Bond
19
19
Electrical /Electronic Property Problem
19
19
Unable to Obtain Readings
18
18
Physical Resistance/Sticking
18
18
Thermal Decomposition of Device
17
17
Component Misassembled
16
16
Failure of Device to Self-Test
16
16
Contamination /Decontamination Problem
16
16
Short Fill
15
15
Suction Problem
15
15
Solder Joint Fracture
14
14
Loose or Intermittent Connection
14
14
Unexpected Shutdown
14
14
Naturally Worn
13
13
Mechanical Problem
13
13
Partial Blockage
13
13
No Apparent Adverse Event
12
12
Intermittent Loss of Power
12
12
Crack
11
11
Image Display Error/Artifact
11
11
Inadequate or Insufficient Training
10
10
Device Contamination with Chemical or Other Material
10
10
Suction Failure
9
9
Inadequacy of Device Shape and/or Size
9
9
Difficult to Remove
9
9
Product Quality Problem
9
9
Inadequate Instructions for Healthcare Professional
9
9
Melted
9
9
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5981
5981
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
653
653
Alteration In Body Temperature
627
627
Patient Problem/Medical Problem
358
358
No Code Available
148
148
Chills
131
131
No Information
108
108
Inadequate Pain Relief
106
106
Insufficient Information
94
94
Shaking/Tremors
72
72
Burn(s)
66
66
Death
48
48
Hypothermia
43
43
Partial thickness (Second Degree) Burn
38
38
Seizures
29
29
Skin Discoloration
29
29
Fever
28
28
Convulsion/Seizure
27
27
Burn, Thermal
25
25
Therapeutic Effects, Unexpected
25
25
Skin Tears
20
20
Pressure Sores
20
20
Blister
19
19
Unspecified Infection
19
19
Erythema
17
17
Bradycardia
17
17
Discomfort
16
16
Injury
15
15
Full thickness (Third Degree) Burn
14
14
Alteration in Body Temperature
14
14
Paralysis
14
14
Rash
13
13
Skin Irritation
13
13
Cardiac Arrest
12
12
Low Blood Pressure/ Hypotension
12
12
Skin Inflammation/ Irritation
11
11
Superficial (First Degree) Burn
11
11
Sepsis
10
10
Pneumonia
10
10
Bacterial Infection
9
9
Necrosis
7
7
Swelling
7
7
Tissue Damage
7
7
Hyperthermia
6
6
Pain
5
5
Sedation
5
5
Respiratory Failure
5
5
Therapeutic Response, Decreased
5
5
Complaint, Ill-Defined
4
4
Pulmonary Edema
4
4
Respiratory Distress
4
4
Twitching
4
4
High Blood Pressure/ Hypertension
4
4
Hypoxia
4
4
Bruise/Contusion
4
4
Cardiopulmonary Arrest
3
3
Abrasion
3
3
Emotional Changes
3
3
Burning Sensation
3
3
Brain Injury
3
3
Skin Inflammation
3
3
Sweating
2
2
Meningitis
2
2
Tissue Breakdown
2
2
Not Applicable
2
2
Confusion/ Disorientation
2
2
Electric Shock
2
2
Chemical Exposure
2
2
Unspecified Tissue Injury
2
2
Cardiogenic Shock
2
2
Urinary Tract Infection
2
2
Local Reaction
2
2
Myocardial Infarction
2
2
Peeling
2
2
Exposure to Body Fluids
2
2
Hemorrhage/Bleeding
2
2
Irritation
2
2
Ischemia
1
1
Itching Sensation
1
1
Laceration(s)
1
1
Overdose
1
1
Inflammation
1
1
Hemorrhage, Cerebral
1
1
Hypersensitivity/Allergic reaction
1
1
Hypovolemic Shock
1
1
Air Embolism
1
1
Atrial Fibrillation
1
1
Encephalopathy
1
1
Edema
1
1
Stacking Breaths
1
1
Hematoma
1
1
Tachycardia
1
1
Septic Shock
1
1
Shock
1
1
Ventricular Fibrillation
1
1
Ventricular Tachycardia
1
1
Respiratory Distress Syndrome of Newborns
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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