BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 EX - 3005

    MDR report key: 3031152 · Received April 2, 2013

    Report

    Report Number
    0001831750-2013-02794
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 4, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED WITH RESULTS OF EVALUATION. IT WAS FOUND THAT THE FOOTEND OF THE BED WOULD NOT RAISE UP OR LOWER DUE TO A MALFUNCTIONED CPU BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE FOOTEND OF THE BED WOULD NOT RAISE UP OR LOWER. 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 BY REPAIR WORK ORDER THAT THE FOOTEND OF THE BED WOULD NOT RAISE UP OR LOWER. 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
    134187 S3 EX - 3005 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1