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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA INC. PANDA WARMER; WARMER, INFANT RADIANT

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DATEX-OHMEDA INC. PANDA WARMER; WARMER, INFANT RADIANT Back to Search Results
Device Problem Improper Flow or Infusion (2954)
Patient Problem Insufficient Information (4580)
Event Date 09/16/2021
Event Type  malfunction  
Event Description
1st event: infant delivered by c-section and required intubation and resuscitation.On attempt to transfer infant to nicu, air tank on transport warmer found to be empty.Infant had to be rapidly transferred to nicu on 100% o2.After speaking with nicu staff and resp therapists involved; the initial issue seemed to have stemmed from issues with the medical air tank at that time.The air and pressure gauges were working following the collaborative effort to trouble-shoot and correct what was believed to be an empty and/or bad tank at that time.The bed cleaned and placed back into use in the main c/s or (cesarean section operating room).2nd event: this is the second occasion that the same infant warmer failed.This time, the o2 from the oxygen tank would not work.In this case, the oxygen tank was not flowing through the warmer's built-in regulator, but the medical air side was flowing.Cpap pressure was maintained despite decreased/absent oxygen flow.After discussing the fact that this was the second issue with the tanks flowing improperly through the regulator; bed will remain out of service until manufacturer (ge) can inspect the bed.
 
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Brand Name
PANDA WARMER
Type of Device
WARMER, INFANT RADIANT
Manufacturer (Section D)
DATEX-OHMEDA INC.
3030 ohmeda drive
madison WI 53718
MDR Report Key12518580
MDR Text Key272954541
Report Number12518580
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/17/2021
Event Location Hospital
Date Report to Manufacturer09/23/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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