BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC II

    MDR report key: 3251519 · Received June 25, 2013

    Report

    Report Number
    3251519
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    HEAD OF BED NOT GOING UP AND DOWN APPROPRIATELY- BED CHANGED OUT AND BROKEN BED SENT TO BIOMED, COULD NOT FIND ANY SPECIFIC NUMBERS ON BED. IT WAS A STRYKER ZOOM BED WITH POSITION PRO MATTRESS, QUESTION WHETHER FOOT BOARD IS NOT CORRECT MODEL. INCIDENT WAS REPEATED WITH THIS BED WHEN THE HEAD OF BED WOULD NOT ELEVATE WITH ANY OF THE CONTROL BUTTONS ON RAILS OR FOOT OF BED. PATIENT WAS HAVING RESPIRATORY DISTRESS. PATIENT HAD TO BE TAKEN OUT OF BED, AND PLACED IN CARDIAC CHAIR TO EASE WORK OF BREATHING.A SECOND BED MALFUNCTIONED WHEN THE HEAD OF THE BED ONLY GOES UP IN SMALL INCREMENTS, BUT THEN UNABLE TO PUT BACK DOWN. BED IS A STRYKER ZOOM. BED WAS CHECKED PREVIOUSLY AND PUT BACK IN SERVICE NOT SURE IF BED FUNCTIONS APPROPRIATELY WITHOUT WEIGHT OF PATIENT IN BED, BUT THEN MALFUNCTIONS WHEN A PATIENT IS BACK IN IT. INCIDENT WAS REPEATED WHEN THE HEAD OF THE BED WAS WORKING INTERMITTENTLY DURING THE NIGHT, THIS MORNING ONLY GOES UP, BUT THEN UNABLE TO PUT BACK DOWN. BED SCALE ALSO NOT FUNCTIONING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288493 EPIC II BED FNL STRYKER INSTRUMENTS 2040 *
    288630 EPIC II BED FNL STRYKER INSTRUMENTS 2040 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *