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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device incubator, neonatal
Regulation Description Neonatal incubator.
Product CodeFMZ
Regulation Number 880.5400
Device Class 2


Premarket Reviews
ManufacturerDecision
DATEX OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MOM INCUBATORS LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 15 15
2022 27 27
2023 19 19
2024 118 118
2025 254 254
2026 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 166 166
No Flow 62 62
Insufficient Flow or Under Infusion 52 52
Break 43 43
Adverse Event Without Identified Device or Use Problem 18 18
Microbial Contamination of Device 12 12
Infusion or Flow Problem 9 9
Mechanical Problem 8 8
Contamination /Decontamination Problem 7 7
Therapeutic or Diagnostic Output Failure 7 7
Gas/Air Leak 6 6
Calibration Problem 6 6
Insufficient Heating 4 4
Insufficient Information 4 4
Fire 3 3
Excessive Heating 3 3
Loose or Intermittent Connection 3 3
Structural Problem 2 2
Temperature Problem 2 2
Difficult to Open or Close 2 2
Output Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Failure to Calibrate 2 2
Unexpected Therapeutic Results 2 2
Use of Device Problem 2 2
Material Integrity Problem 2 2
Failure to Deliver 2 2
Fluid/Blood Leak 2 2
Device Alarm System 2 2
Display or Visual Feedback Problem 2 2
Crack 2 2
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Power Problem 1 1
Device Handling Problem 1 1
Physical Resistance/Sticking 1 1
Unexpected Shutdown 1 1
Moisture or Humidity Problem 1 1
Fail-Safe Did Not Operate 1 1
Key or Button Unresponsive/not Working 1 1
Unintended Ejection 1 1
Material Discolored 1 1
Deflation Problem 1 1
Corroded 1 1
Use of Incorrect Control/Treatment Settings 1 1
Thermal Decomposition of Device 1 1
Failure to Infuse 1 1
Inaccurate Delivery 1 1
Improper or Incorrect Procedure or Method 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 405 405
Insufficient Information 14 14
Fall 10 10
Skull Fracture 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Hematoma 4 4
Alteration in Body Temperature 3 3
Fungal Infection 2 2
Head Injury 2 2
No Known Impact Or Consequence To Patient 2 2
Burn(s) 2 2
Hypothermia 2 2
Death 1 1
Sepsis 1 1
Emotional Changes 1 1
Fever 1 1
Hypernatremia 1 1
Pain 1 1
Bradycardia 1 1
Limb Fracture 1 1
No Consequences Or Impact To Patient 1 1
Irritability 1 1
Low Oxygen Saturation 1 1
Bruise/Contusion 1 1
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Aug-16-2021
2 DATEX--OHMEDA, INC. I Oct-31-2024
3 DATEX--OHMEDA, INC. I Oct-17-2024
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 Wipro GE Healthcare Private Ltd. I Feb-09-2024
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