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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

MDR Year MDR Reports MDR Events
2020 8 8
2021 15 15
2022 27 27
2023 19 19
2024 118 118
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 42 42
Insufficient Flow or Under Infusion 30 30
Adverse Event Without Identified Device or Use Problem 17 17
Microbial Contamination of Device 11 11
No Flow 9 9
Infusion or Flow Problem 7 7
Contamination /Decontamination Problem 7 7
Break 7 7
Mechanical Problem 7 7
Calibration Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Gas/Air Leak 4 4
Insufficient Heating 4 4
Insufficient Information 4 4
Excessive Heating 3 3
Fire 3 3
Device Alarm System 2 2
Unexpected Therapeutic Results 2 2
Structural Problem 2 2
Loose or Intermittent Connection 2 2
Failure to Calibrate 2 2
Fluid/Blood Leak 2 2
Temperature Problem 2 2
Crack 2 2
Output Problem 2 2
Device Emits Odor 1 1
Moisture Damage 1 1
Device Sensing Problem 1 1
Failure to Deliver 1 1
Use of Incorrect Control/Treatment Settings 1 1
Self-Activation or Keying 1 1
Electrical Shorting 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Shutdown 1 1
Decreased Sensitivity 1 1
Corroded 1 1
Display or Visual Feedback Problem 1 1
Material Opacification 1 1
Key or Button Unresponsive/not Working 1 1
Device Contamination with Chemical or Other Material 1 1
Difficult to Open or Close 1 1
Device Handling Problem 1 1
Moisture or Humidity Problem 1 1
Material Integrity Problem 1 1
Smoking 1 1
Sparking 1 1
Thermal Decomposition of Device 1 1
Failure to Infuse 1 1
Use of Device Problem 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 157 157
Insufficient Information 13 13
Fall 9 9
Skull Fracture 5 5
Hematoma 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Fungal Infection 2 2
Burn(s) 2 2
Head Injury 2 2
Hypothermia 2 2
Alteration in Body Temperature 2 2
No Known Impact Or Consequence To Patient 2 2
Death 1 1
Limb Fracture 1 1
Low Oxygen Saturation 1 1
Emotional Changes 1 1
Bradycardia 1 1
Pain 1 1
Bruise/Contusion 1 1
No Consequences Or Impact To Patient 1 1
Irritability 1 1
Distress 1 1
Hypernatremia 1 1
Sepsis 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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