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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 223 223

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 158 158
Insufficient Flow or Under Infusion 47 47
No Flow 42 42
Break 38 38
Adverse Event Without Identified Device or Use Problem 18 18
Microbial Contamination of Device 11 11
Infusion or Flow Problem 9 9
Mechanical Problem 7 7
Contamination /Decontamination Problem 7 7
Therapeutic or Diagnostic Output Failure 6 6
Calibration Problem 5 5
Gas/Air Leak 5 5
Insufficient Heating 4 4
Insufficient Information 4 4
Loose or Intermittent Connection 3 3
Excessive Heating 3 3
Fire 3 3
Material Integrity Problem 2 2
Difficult to Open or Close 2 2
Failure to Deliver 2 2
Unexpected Therapeutic Results 2 2
Crack 2 2
Device Alarm System 2 2
Structural Problem 2 2
Output Problem 2 2
Failure to Calibrate 2 2
Fluid/Blood Leak 2 2
Temperature Problem 2 2
Corroded 1 1
Display or Visual Feedback Problem 1 1
Battery Problem: High Impedance 1 1
Self-Activation or Keying 1 1
Overheating of Device 1 1
Nonstandard Device 1 1
Appropriate Term/Code Not Available 1 1
Improper or Incorrect Procedure or Method 1 1
Power Problem 1 1
Failure to Infuse 1 1
Inaccurate Delivery 1 1
No Apparent Adverse Event 1 1
Device Contamination with Chemical or Other Material 1 1
Electrical Shorting 1 1
Device Sensing Problem 1 1
Decreased Sensitivity 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
Thermal Decomposition of Device 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 362 362
Insufficient Information 13 13
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
Emotional Changes 1 1
Sepsis 1 1
Pain 1 1
Hypernatremia 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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