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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device incubator, neonatal transport
Product CodeFPL
Regulation Number 880.5410
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ATOM MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2016 1 1
2018 2 2
2020 1 1
2021 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Smoking 3 3
Thermal Decomposition of Device 2 2
Loose or Intermittent Connection 2 2
Device Emits Odor 2 2
Overheating of Device 1 1
Loss of Power 1 1
Device Slipped 1 1
Failure to Charge 1 1
Corroded 1 1
Disconnection 1 1
Leak/Splash 1 1
Defective Component 1 1
Failure to Deliver 1 1
Device Operates Differently Than Expected 1 1
Gas/Air Leak 1 1
Material Deformation 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
No Information 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical Systems, Inc. II Jul-12-2022
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