BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANDA IRES WARMER

    MDR report key: 16731844 · Received April 13, 2023

    Report

    Report Number
    16731844
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    January 26, 2023
    Report Date
    April 4, 2023
    Manufacturer
    GE HEALTHCARE, LLC
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CONCERN RAISED REGARDING THE AMOUNT OF OXYGEN BEING DELIVERED TO NEWBORNS WAS CORRECT. IT WAS IDENTIFIED DURING EQUIPMENT CHECK THAT O2 DIAL ON THE WARMER BED DID NOT FEEL RIGHT WHEN TURNING. EVALUATED AND LOOSE DIAL IDENTIFIED WITH POTENTIAL CONCERN INTERNAL VALVE SHAFT NOT FUNCTIONING. BED/O2 BLENDER SYSTEM SENT FOR EVALUATION AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026469 PANDA IRES WARMER WARMER, INFANT RADIANT FMT GE HEALTHCARE, LLC M1112198

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown