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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL SYTEMS, 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
2018 18 18
2019 24 24
2020 8 8
2021 15 15
2022 27 27
2023 19 19
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17
Microbial Contamination of Device 11 11
Appropriate Term/Code Not Available 10 10
Contamination /Decontamination Problem 7 7
Contamination 6 6
Mechanical Problem 5 5
Excessive Heating 5 5
Temperature Problem 4 4
Insufficient Information 4 4
Insufficient Heating 4 4
Break 4 4
Crack 3 3
Loose or Intermittent Connection 3 3
Calibration Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Output Problem 2 2
Fluid/Blood Leak 2 2
Structural Problem 2 2
Overheating of Device 2 2
Unexpected Therapeutic Results 2 2
Display or Visual Feedback Problem 2 2
Device Alarm System 2 2
Loss of or Failure to Bond 1 1
Thermal Decomposition of Device 1 1
Component Falling 1 1
Unintended Ejection 1 1
Fire 1 1
Incorrect Measurement 1 1
Use of Incorrect Control/Treatment Settings 1 1
Corroded 1 1
Moisture Damage 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Insufficient Flow or Under Infusion 1 1
Defective Component 1 1
Self-Activation or Keying 1 1
Device Slipped 1 1
Smoking 1 1
Decreased Sensitivity 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Battery Problem 1 1
Inaccurate Delivery 1 1
Positioning Problem 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Device Sensing Problem 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Fail-Safe Did Not Operate 1 1
Key or Button Unresponsive/not Working 1 1
Patient Device Interaction Problem 1 1
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
Fall 13 13
Insufficient Information 11 11
No Patient Involvement 9 9
Skull Fracture 8 8
Death 7 7
Bacterial Infection 6 6
Hematoma 6 6
No Known Impact Or Consequence To Patient 5 5
Alteration In Body Temperature 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Consequences Or Impact To Patient 3 3
Hyperthermia 2 2
Hypothermia 2 2
Burn(s) 2 2
Head Injury 2 2
Alteration in Body Temperature 2 2
Burn, Thermal 2 2
No Information 2 2
Injury 2 2
Irritability 1 1
Skin Tears 1 1
Tissue Breakdown 1 1
Limb Fracture 1 1
Emotional Changes 1 1
Cardiac Arrest 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Pain 1 1
Rash 1 1
Sepsis 1 1
Hypernatremia 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 GE Healthcare, LLC II Nov-19-2018
7 Ohmeda Medical II Oct-04-2019
8 Wipro GE Healthcare Private Ltd. I Feb-09-2024
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