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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
DRÄGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 1
MOM INCUBATORS LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 15 15
2022 27 27
2023 19 19
2024 118 118
2025 254 254
2026 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 169 169
No Flow 70 70
Insufficient Flow or Under Infusion 53 53
Break 44 44
Adverse Event Without Identified Device or Use Problem 18 18
Microbial Contamination of Device 12 12
Mechanical Problem 9 9
Infusion or Flow Problem 9 9
Therapeutic or Diagnostic Output Failure 7 7
Contamination /Decontamination Problem 7 7
Gas/Air Leak 6 6
Calibration Problem 6 6
Insufficient Heating 5 5
Insufficient Information 4 4
Excessive Heating 3 3
Fluid/Blood Leak 2 2
Fire 2 2
Output Problem 2 2
Loose or Intermittent Connection 2 2
Display or Visual Feedback Problem 2 2
Difficult to Open or Close 2 2
Material Integrity Problem 2 2
Failure to Deliver 2 2
Failure to Calibrate 2 2
Use of Device Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Temperature Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Battery Problem: High Impedance 1 1
Self-Activation or Keying 1 1
Overheating of Device 1 1
Nonstandard Device 1 1
Power Problem 1 1
Failure to Infuse 1 1
No Apparent Adverse Event 1 1
Electrical Shorting 1 1
Device Emits Odor 1 1
Device Handling Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Moisture or Humidity Problem 1 1
Structural Problem 1 1
Thermal Decomposition of Device 1 1
Failure to Power Up 1 1
Unintended Ejection 1 1
Material Discolored 1 1
Battery Problem 1 1
Key or Button Unresponsive/not Working 1 1
Deflation Problem 1 1
Defective Device 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 418 418
Insufficient Information 14 14
Fall 9 9
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
Hypothermia 2 2
Bradycardia 2 2
Sepsis 1 1
Emotional Changes 1 1
Burn(s) 1 1
Fever 1 1
Pain 1 1
Limb Fracture 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 Wipro GE Healthcare Private Ltd. I Feb-09-2024
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