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TPLC
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Device
incubator, neonatal transport
Product Code
FPL
Regulation Number
880.5410
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
2
2
2020
1
1
2021
2
2
2022
1
1
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Emits Odor
2
2
Smoking
2
2
Leak/Splash
1
1
Disconnection
1
1
Failure to Deliver
1
1
Thermal Decomposition of Device
1
1
Material Deformation
1
1
Device Operates Differently Than Expected
1
1
Gas/Air Leak
1
1
Corroded
1
1
Loss of Power
1
1
Mechanical Problem
1
1
Break
1
1
Defective Component
1
1
Overheating of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
3
3
Insufficient Information
3
3
No Clinical Signs, Symptoms or Conditions
1
1
Alteration in Body Temperature
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Draeger Medical Systems, Inc.
II
Jul-12-2022
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