BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANDA IRES WARMER

    MDR report key: 16736947 · Received April 13, 2023

    Report

    Report Number
    2112667-2023-01984
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    March 5, 2023
    Report Date
    August 19, 2023
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMT
    PMA / PMN Number
    K122267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE GE HEALTHCARE INVESTIGATION CONCLUDED THAT THE GEHC DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE FIRE. EXTERNAL TESTING RESULTS SHOW THAT NONE OF THE METALLIC MATERIAL IDENTIFIED WITHIN SINGED MATERIALS IS CONSISTENT WITH THE MATERIALS COMPRISED WITHIN THE HEATER HEAD ASSEMBLY. THERE WERE NO TRACES OF METAL AND THE MATERIAL CONSISTED PRIMARILY OF MELTED PLASTIC, A FIBROUS MATERIAL WITH BLUE COLORATION FROM THE CHUX. ADDITIONALLY, AN ENGINEERING ASSESSMENT DETERMINED THAT SHOULD ANY MATERIAL FLAKE FROM THE HEATER ASSEMBLY, IT WOULD HAVE SUFFICIENT THERMAL ENERGY TO IGNITE ANY MATERIAL.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A1, A3, A4, A5, AND A6: INFORMATION NOT PROVIDED. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226. H3 OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED FIRE INSIDE A PANDA IRES WARMER DURING PATIENT USE IN THE TREATMENT ROOM OF THE MOTHER BABY UNIT. THE NURSE IMMEDIATELY REMOVED THE INFANT. THERE WAS NO INJURY TO PATIENT OR STAFF. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245047 PANDA IRES WARMER WARMER, INFANT RADIANT FMT DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown