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TPLC
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Device
warmer, infant radiant
Regulation Description
Infant radiant warmer.
Product Code
FMT
Regulation Number
880.5130
Device Class
2
Premarket Reviews
Manufacturer
Decision
DATEX OHMEDA INC.
SUBSTANTIALLY EQUIVALENT
1
DEROYAL INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
2
DRAEGER MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
GE HEALTHCARE
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
1605
1605
2021
473
473
2022
153
153
2023
176
176
2024
257
257
2025
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Integrity Problem
1972
1972
Break
191
191
Pressure Problem
111
111
Crack
102
102
Insufficient Flow or Under Infusion
51
51
Device Alarm System
35
35
Nonstandard Device
32
32
Gas/Air Leak
21
21
Output Problem
21
21
No Audible Alarm
20
20
Incorrect, Inadequate or Imprecise Result or Readings
20
20
Fracture
18
18
Mechanical Problem
15
15
Detachment of Device or Device Component
14
14
Therapeutic or Diagnostic Output Failure
12
12
Device Sensing Problem
10
10
Microbial Contamination of Device
10
10
Product Quality Problem
8
8
Electrical /Electronic Property Problem
8
8
Contamination
8
8
Device Damaged Prior to Use
7
7
Smoking
6
6
Overheating of Device
6
6
Melted
6
6
No Flow
6
6
Defective Alarm
5
5
Fire
4
4
Loss of or Failure to Bond
4
4
Excessive Heating
4
4
Unable to Obtain Readings
4
4
Insufficient Information
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Infusion or Flow Problem
3
3
Temperature Problem
3
3
Unexpected Therapeutic Results
3
3
Loose or Intermittent Connection
3
3
Power Problem
3
3
No Apparent Adverse Event
3
3
Electrical Shorting
3
3
Thermal Decomposition of Device
3
3
Circuit Failure
3
3
Material Fragmentation
2
2
Device Dislodged or Dislocated
2
2
Suction Failure
2
2
Device Displays Incorrect Message
2
2
Protective Measures Problem
2
2
Structural Problem
2
2
Device Fell
2
2
Insufficient Heating
2
2
Failure to Sense
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
1188
1188
No Clinical Signs, Symptoms or Conditions
1100
1100
Insufficient Information
327
327
No Known Impact Or Consequence To Patient
28
28
Alteration in Body Temperature
10
10
Fall
6
6
Burn(s)
4
4
Skull Fracture
3
3
Low Oxygen Saturation
3
3
Superficial (First Degree) Burn
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Inadequate Osseointegration
2
2
Hyperthermia
2
2
No Consequences Or Impact To Patient
2
2
External Prosthetic Device Pain
1
1
Full thickness (Third Degree) Burn
1
1
Bone Fracture(s)
1
1
Fungal Infection
1
1
Bradycardia
1
1
Fever
1
1
Hemorrhage/Bleeding
1
1
Hypothermia
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Draeger Medical Systems, Inc.
II
Jun-22-2023
2
Wipro GE Healthcare Private Ltd.
II
Sep-20-2024
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