BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNATIONAL EPIC ICU BED

    MDR report key: 1928613 · Received November 24, 2010

    Report

    Report Number
    1831750-2010-04222
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 31, 2010
    Report Date
    October 31, 2010
    Manufacturer
    STRYKER CORP, MEDICAL DEV.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: REPLACEMENT PART HAS BEEN REQUESTED FOR THE CUSTOMER.

    Description of Event or Problem · 1

    THE DISTRIBUTOR (B)(4) REPORTED THAT THE BED DOES NOT GO UP AND DOWN FROM THE HEAD SIDE. THE DISTRIBUTOR (B)(4) REPORTED THAT THEY CHECKED THE MAIN BOARD AND FOUND AN OUTPUT FAULTY IN THE SOCKET OF THE HEAD UP AND DOWN MOTOR. THE DISTRIBUTOR REPORTED THAT THE BED NEEDS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERNATIONAL EPIC ICU BED AC POWERED HOSPITAL BED FNL STRYKER CORP, MEDICAL DEV. 2031 NA

    Patients

    Seq Age Sex Outcome Treatment
    1