BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBL PACKAGE, VERITER 5TH WHEEL SIDNE ENABLED ASSY

    MDR report key: 1234060 · Received November 4, 2008

    Report

    Report Number
    2031963-2008-00022
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS BEING REQUESTED FROM THE CUSTOMER. WHEN RECEIVED, IT WILL BE SUBMITTED VIA SUPPLEMENTAL REPORT. DEVICE MANUFACTURED DATE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT AS WELL. ONCE AN EVALUATION OF THE PRODUCT IS CONDUCTED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE STOPPED WORKING WITH THE RED LIGHT BLINKING. ADDITIONALLY, IT WAS REPORTED THAT THE HOSPITAL STAFF WERE UNABLE TO GET THE LEGS UP AND THAT NUMEROUS BUTTONS WERE PUSHED AND THE TABLE FINALLY BEGAN WORKING. IT WAS REPORTED FROM THE CUSTOMER THAT THERE WAS A DELAY OF GREATER THAN 30 MINUTES IN SURGERY DUE TO THE DEVICE MALFUNCTION. IT WAS ALSO REPORTED THAT ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBL PACKAGE, VERITER 5TH WHEEL SIDNE ENABLED ASSY SURGICAL TABLE FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK