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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
2020 8 8
2021 15 15
2022 27 27
2023 19 19
2024 118 118
2025 254 254
2026 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 176 176
No Flow 77 77
Insufficient Flow or Under Infusion 55 55
Break 44 44
Adverse Event Without Identified Device or Use Problem 18 18
Microbial Contamination of Device 12 12
Mechanical Problem 10 10
Infusion or Flow Problem 9 9
Therapeutic or Diagnostic Output Failure 7 7
Contamination /Decontamination Problem 7 7
Calibration Problem 6 6
Gas/Air Leak 6 6
Insufficient Heating 5 5
Insufficient Information 4 4
Fire 3 3
Loose or Intermittent Connection 3 3
Difficult to Open or Close 3 3
Excessive Heating 3 3
Temperature Problem 2 2
Fluid/Blood Leak 2 2
Display or Visual Feedback Problem 2 2
Unexpected Therapeutic Results 2 2
Failure to Calibrate 2 2
No Apparent Adverse Event 2 2
Device Contamination with Chemical or Other Material 2 2
Structural Problem 2 2
Use of Device Problem 2 2
Failure to Deliver 2 2
Material Integrity Problem 2 2
Crack 2 2
Device Alarm System 2 2
Output Problem 2 2
Failure to Power Up 1 1
Unintended Ejection 1 1
Material Discolored 1 1
Thermal Decomposition of Device 1 1
Battery Problem 1 1
Key or Button Unresponsive/not Working 1 1
Moisture or Humidity Problem 1 1
Moisture Damage 1 1
Use of Incorrect Control/Treatment Settings 1 1
Deflation Problem 1 1
Device Handling Problem 1 1
Device Emits Odor 1 1
Decreased Sensitivity 1 1
Device Sensing Problem 1 1
Electrical Shorting 1 1
Defective Device 1 1
Smoking 1 1
Inaccurate Delivery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 438 438
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
Bradycardia 2 2
Death 1 1
Sepsis 1 1
Emotional Changes 1 1
Fever 1 1
Hypernatremia 1 1
Pain 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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