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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
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
NINGBO DAVID MEDICAL DEVICE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 24 24
2020 8 8
2021 15 15
2022 27 27
2023 19 19
2024 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17
Insufficient Flow or Under Infusion 15 15
Microbial Contamination of Device 10 10
Mechanical Problem 8 8
Appropriate Term/Code Not Available 8 8
Contamination /Decontamination Problem 7 7
Excessive Heating 5 5
Temperature Problem 4 4
Break 4 4
Insufficient Information 4 4
Therapeutic or Diagnostic Output Failure 4 4
Insufficient Heating 4 4
Gas/Air Leak 4 4
Calibration Problem 4 4
Crack 3 3
Fluid/Blood Leak 2 2
No Flow 2 2
Fire 2 2
Output Problem 2 2
Device Alarm System 2 2
Loose or Intermittent Connection 2 2
Display or Visual Feedback Problem 2 2
Unexpected Therapeutic Results 2 2
Structural Problem 2 2
Failure to Calibrate 2 2
Improper or Incorrect Procedure or Method 1 1
Corroded 1 1
Self-Activation or Keying 1 1
Overheating of Device 1 1
Nonstandard Device 1 1
Protective Measures Problem 1 1
Power Problem 1 1
Device Dislodged or Dislocated 1 1
Failure to Infuse 1 1
Inaccurate Delivery 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
Incorrect Measurement 1 1
Device Handling Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Thermal Decomposition of Device 1 1
Use of Device Problem 1 1
Unintended Ejection 1 1
Battery Problem 1 1
Key or Button Unresponsive/not Working 1 1
Failure to Deliver 1 1
Moisture Damage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 71 71
Insufficient Information 12 12
Fall 12 12
No Patient Involvement 9 9
Skull Fracture 8 8
Death 5 5
Hematoma 5 5
No Known Impact Or Consequence To Patient 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Fungal Infection 2 2
Head Injury 2 2
Alteration In Body Temperature 2 2
Burn(s) 2 2
Alteration in Body Temperature 2 2
Hypothermia 2 2
Hyperthermia 2 2
No Consequences Or Impact To Patient 2 2
Emotional Changes 1 1
Sepsis 1 1
Injury 1 1
Pain 1 1
Hypernatremia 1 1
Bradycardia 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. II Jul-06-2023
3 GE Healthcare, LLC II Jun-15-2020
4 GE Healthcare, LLC II May-22-2020
5 GE Healthcare, LLC II Nov-04-2019
6 Ohmeda Medical II Oct-04-2019
7 Wipro GE Healthcare Private Ltd. I Feb-09-2024
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