BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II

    MDR report key: 3130445 · Received May 24, 2013

    Report

    Report Number
    0001831750-2013-04759
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH EVAULATION RESULTS. AN INSPECTION WAS ALLEGEDLY PERFORMED BY AN UNKNOWN INDIVIDUAL AT (B)(6). THE ALLEGED INSPECTION IDENTIFIED THAT THERE WAS NO MOTOR FUNCTIONS DUE TO A FAULTY MOTOR CONTROL BOARDCUSTOMER ORDERED NEW MOTOR CONTROL BOARD TO DO REPAIR. ALLEGEDLY PERFORMED BY CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THERE WAS A LOSS OF MOTOR FUNCTIONS ALLEGEDLY FROM A MOTOR CONTROL BOARD MALFUNCTION. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT MOTOR CONTROL BOARD MALFUNCTIONED WHICH MAY HAVE CAUSED A LOSS OF MOTOR FUNCTIONS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231891 GOBED II BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1