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TPLC
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show TPLC since
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Device
incubator, neonatal
Product Code
FMZ
Regulation Number
880.5400
Device Class
2
Premarket Reviews
Manufacturer
Decision
DATEX OHMEDA INC.
SUBSTANTIALLY EQUIVALENT
1
DRAGERWERK AG & CO. KGAA
SUBSTANTIALLY EQUIVALENT
1
NINGBO DAVID MEDICAL DEVICE CO.,LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
24
24
2020
8
8
2021
15
15
2022
27
27
2023
19
19
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
14
14
Microbial Contamination of Device
10
10
Appropriate Term/Code Not Available
8
8
Contamination /Decontamination Problem
7
7
Mechanical Problem
5
5
Excessive Heating
5
5
Temperature Problem
4
4
Break
4
4
Insufficient Heating
4
4
Crack
3
3
Insufficient Information
3
3
Therapeutic or Diagnostic Output Failure
2
2
Output Problem
2
2
Display or Visual Feedback Problem
2
2
Loose or Intermittent Connection
2
2
Device Alarm System
2
2
Fluid/Blood Leak
2
2
Unexpected Therapeutic Results
2
2
Structural Problem
2
2
Decreased Sensitivity
1
1
Sparking
1
1
Battery Problem
1
1
Device Sensing Problem
1
1
Device Dislodged or Dislocated
1
1
Electrical Shorting
1
1
Material Integrity Problem
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Insufficient Flow or Under Infusion
1
1
Defective Component
1
1
Incorrect Measurement
1
1
Unintended Ejection
1
1
Fire
1
1
Thermal Decomposition of Device
1
1
Use of Incorrect Control/Treatment Settings
1
1
Corroded
1
1
Moisture Damage
1
1
Nonstandard Device
1
1
Device Emits Odor
1
1
Overheating of Device
1
1
Self-Activation or Keying
1
1
Device Slipped
1
1
Smoking
1
1
Power Problem
1
1
Protective Measures Problem
1
1
Inaccurate Delivery
1
1
Fail-Safe Did Not Operate
1
1
Key or Button Unresponsive/not Working
1
1
Unintended Electrical Shock
1
1
Unexpected Shutdown
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
35
35
Fall
12
12
Insufficient Information
11
11
No Patient Involvement
9
9
Skull Fracture
8
8
Death
5
5
Hematoma
5
5
No Known Impact Or Consequence To Patient
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Burn(s)
2
2
Alteration in Body Temperature
2
2
Hyperthermia
2
2
Hypothermia
2
2
No Consequences Or Impact To Patient
2
2
Alteration In Body Temperature
2
2
Head Injury
2
2
Hypernatremia
1
1
Distress
1
1
Injury
1
1
Irritability
1
1
Pain
1
1
Sepsis
1
1
Emotional Changes
1
1
Bradycardia
1
1
Bruise/Contusion
1
1
Limb Fracture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CooperSurgical, Inc.
II
Aug-16-2021
2
DATEX--OHMEDA, INC.
II
Jul-06-2023
3
GE Healthcare, LLC
II
Jun-15-2020
4
GE Healthcare, LLC
II
May-22-2020
5
GE Healthcare, LLC
II
Nov-04-2019
6
Ohmeda Medical
II
Oct-04-2019
7
Wipro GE Healthcare Private Ltd.
I
Feb-09-2024
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