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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device incubator, neonatal
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

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 31 31
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
Break 7 7
Mechanical Problem 7 7
Contamination /Decontamination Problem 7 7
Calibration Problem 5 5
Insufficient Information 4 4
Insufficient Heating 4 4
Gas/Air Leak 4 4
Infusion or Flow Problem 4 4
Fire 3 3
Therapeutic or Diagnostic Output Failure 3 3
Excessive Heating 3 3
Temperature Problem 2 2
Fluid/Blood Leak 2 2
Output Problem 2 2
Device Alarm System 2 2
Crack 2 2
Loose or Intermittent Connection 2 2
Unexpected Therapeutic Results 2 2
Structural Problem 2 2
Failure to Calibrate 2 2
Improper or Incorrect Procedure or Method 1 1
Display or Visual Feedback Problem 1 1
Corroded 1 1
Difficult to Open or Close 1 1
Self-Activation or Keying 1 1
Overheating of Device 1 1
Nonstandard Device 1 1
Appropriate Term/Code Not Available 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
Failure to Power Up 1 1
Unintended Ejection 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 141 141
Insufficient Information 13 13
Fall 9 9
Skull Fracture 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Hematoma 4 4
Fungal Infection 2 2
Head Injury 2 2
No Known Impact Or Consequence To Patient 2 2
Burn(s) 2 2
Alteration in Body Temperature 2 2
Hypothermia 2 2
Death 1 1
Sepsis 1 1
Emotional Changes 1 1
Hypernatremia 1 1
Pain 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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