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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
ATOM MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
3
BISTOS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
DATEX OHMEDA INC.
SUBSTANTIALLY EQUIVALENT
1
DRAEGER MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
DRAEGER MEDICAL SYTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
DRAEGERWERK AG & CO. KGAA
SUBSTANTIALLY EQUIVALENT
1
DRAGERWERK AG & CO. KGAA
SUBSTANTIALLY EQUIVALENT
1
NINGBO DAVID MEDICAL DEVICE CO.,LTD
SUBSTANTIALLY EQUIVALENT
1
OHMEDA MEDICAL
SUBSTANTIALLY EQUIVALENT
2
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.
SUBSTANTIALLY EQUIVALENT
1
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA,INC. A GE COMPANY
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
9
9
2016
12
12
2017
4
4
2018
18
18
2019
24
24
2020
8
8
2021
15
15
2022
27
27
2023
19
19
2024
47
47
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
22
22
Insufficient Flow or Under Infusion
16
16
Microbial Contamination of Device
11
11
Appropriate Term/Code Not Available
10
10
Mechanical Problem
9
9
Contamination /Decontamination Problem
7
7
Device Operates Differently Than Expected
6
6
Break
6
6
Insufficient Information
6
6
Contamination
6
6
Device Displays Incorrect Message
6
6
Excessive Heating
5
5
Temperature Problem
4
4
Fire
4
4
Device Emits Odor
4
4
Insufficient Heating
4
4
Calibration Problem
4
4
Therapeutic or Diagnostic Output Failure
4
4
Gas/Air Leak
4
4
Crack
3
3
Failure to Calibrate
3
3
Loose or Intermittent Connection
3
3
Battery Problem
3
3
Power Problem
2
2
Structural Problem
2
2
Charging Problem
2
2
Unexpected Therapeutic Results
2
2
Overheating of Device
2
2
Use of Device Problem
2
2
Display or Visual Feedback Problem
2
2
Positioning Problem
2
2
Smoking
2
2
No Flow
2
2
Kinked
2
2
Device Alarm System
2
2
Output Problem
2
2
Fluid/Blood Leak
2
2
Difficult to Open or Close
1
1
Device Inoperable
1
1
Loss of Power
1
1
Self-Activation or Keying
1
1
Corroded
1
1
Premature Discharge of Battery
1
1
Nonstandard Device
1
1
Improper or Incorrect Procedure or Method
1
1
Electrical /Electronic Property Problem
1
1
Melted
1
1
Device Dislodged or Dislocated
1
1
Protective Measures Problem
1
1
Detachment Of Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
71
71
No Known Impact Or Consequence To Patient
18
18
Fall
14
14
Insufficient Information
12
12
No Information
11
11
No Patient Involvement
11
11
Skull Fracture
8
8
Hematoma
8
8
Death
7
7
Bacterial Infection
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Head Injury
3
3
Alteration In Body Temperature
3
3
No Consequences Or Impact To Patient
3
3
Sepsis
2
2
Fungal Infection
2
2
Burn, Thermal
2
2
Injury
2
2
Burn(s)
2
2
Alteration in Body Temperature
2
2
Hypothermia
2
2
Hyperthermia
2
2
Low Blood Pressure/ Hypotension
2
2
Emotional Changes
1
1
Bone Fracture(s)
1
1
Cardiac Arrest
1
1
Rash
1
1
Hypernatremia
1
1
Pain
1
1
Bradycardia
1
1
Limb Fracture
1
1
Skin Tears
1
1
Irritability
1
1
Tissue Breakdown
1
1
Low Oxygen Saturation
1
1
Bruise/Contusion
1
1
Distress
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atom Medical Corporation
II
Jul-06-2012
2
Atom Medical Corporation
II
Dec-01-2011
3
CooperSurgical, Inc.
II
Aug-16-2021
4
DATEX--OHMEDA, INC.
II
Jul-06-2023
5
GE Healthcare, LLC
II
Jun-15-2020
6
GE Healthcare, LLC
II
May-22-2020
7
GE Healthcare, LLC
II
Nov-04-2019
8
GE Healthcare, LLC
II
Nov-19-2018
9
GE Healthcare, LLC
I
Apr-05-2013
10
Maquet Datascope Corp - Cardiac Assist Division
I
Jun-13-2011
11
Natus Medical Incorporated
II
Oct-07-2016
12
Natus Medical Incorporated
II
Apr-11-2016
13
Ohmeda Medical
II
Oct-04-2019
14
Ohmeda Medical
II
Mar-20-2017
15
Wipro GE Healthcare Private Ltd.
I
Feb-09-2024
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