• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14 14
Microbial Contamination of Device 10 10
Appropriate Term/Code Not Available 8 8
Contamination /Decontamination Problem 7 7
Mechanical Problem 5 5
Excessive Heating 5 5
Temperature Problem 4 4
Break 4 4
Insufficient Heating 4 4
Crack 3 3
Therapeutic or Diagnostic Output Failure 3 3
Insufficient Information 3 3
Calibration Problem 3 3
Output Problem 2 2
Display or Visual Feedback Problem 2 2
Loose or Intermittent Connection 2 2
Device Alarm System 2 2
Fluid/Blood Leak 2 2
Unexpected Therapeutic Results 2 2
Structural Problem 2 2
Decreased Sensitivity 1 1
Sparking 1 1
Battery 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
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
Incorrect Measurement 1 1
Unintended Ejection 1 1
Fire 1 1
Thermal Decomposition of Device 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
Overheating of Device 1 1
Self-Activation or Keying 1 1
Device Slipped 1 1
Smoking 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Inaccurate Delivery 1 1
Fail-Safe Did Not Operate 1 1
Key or Button Unresponsive/not Working 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 12 12
Insufficient Information 11 11
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
Burn(s) 2 2
Alteration in Body Temperature 2 2
Hyperthermia 2 2
Hypothermia 2 2
No Consequences Or Impact To Patient 2 2
Alteration In Body Temperature 2 2
Head Injury 2 2
Hypernatremia 1 1
Distress 1 1
Injury 1 1
Irritability 1 1
Pain 1 1
Sepsis 1 1
Emotional Changes 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Limb Fracture 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
-
-