BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSALET INFANT INCUBATOR/RADI P84

    MDR report key: 387327 · Received April 6, 2002

    Report

    Report Number
    2510954-2002-00002
    Event Type
    Malfunction
    Date Received
    April 6, 2002
    Date of Event
    March 6, 2002
    Report Date
    March 18, 2002
    Manufacturer
    HILL-ROM AIRSHIELDS
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    2002 SITUATION WAS DESCRIBED: THE BED HAS BEEN TOO WARM IN INCUBATOR MODE, NURSE HAD TURNED UNIT OFF TEMPORARILY. RESP THERAPIST AND X-RAY TECH WANTED TO MAKE MORNING X-RAY. PLATFORM ASSEMBLY AND OHA WERE IN THE LOWEST POSITION (INCUBATOR). THEY DECIDED THEY NEEDED TO RAISE OHA TO COMPLETE X-RAY, PUSHED UP ARROW ON OHA, UNIT DID NOT RAISE, THEN NOTICED POWER WAS OFF, THEN POWERED UNIT ON. UNIT FINISHED SELF CHECK THEN SPONTANEOUSLY, WHOLE PLATFORM WENT UP, NURSE PUSHED DOWN ARROW TO STOP UNIT FROM RAISING, UNIT WOULD NOT STOP. AS UNIT WENT UP THE SHELF CAUGHT ON THE EPICARE POWER COLUMN THEN BROKE OFF. THE SHELF WAS HOLDING A SATURATION TCM, A TRANSCUTARIOUS MONITOR AND CALIBRATION TANKS (MEDGAS). TECH CAUGHT THE SHELF AS IT BROKE OFF PREVENTING CONTENTS FROM FALLING. VENTILATOR TUBING WAS REACHING FULL EXTENSION CAPABILITY WHEN CHARGE NURSE UNPLUGGED UNIT AND IT STOPPED RAISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSALET INFANT INCUBATOR/RADI P84 COMBINATION INCUBATOR/WARMER FMZ HILL-ROM AIRSHIELDS 7700 CARE CENTER *

    Patients

    Seq Age Sex Outcome Treatment
    1 *