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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 66 66

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 176 176
No Flow 87 87
Insufficient Flow or Under Infusion 56 56
Break 48 48
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
Gas/Air Leak 6 6
Calibration Problem 6 6
Insufficient Heating 5 5
Insufficient Information 4 4
Output Problem 3 3
Difficult to Open or Close 3 3
Excessive Heating 3 3
Use of Device Problem 3 3
No Apparent Adverse Event 3 3
Fluid/Blood Leak 2 2
Fire 2 2
Loose or Intermittent Connection 2 2
Display or Visual Feedback Problem 2 2
Material Integrity Problem 2 2
Failure to Deliver 2 2
Failure to Calibrate 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
Inaccurate Delivery 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 455 455
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
Emotional Changes 1 1
Sepsis 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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