BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II MED/SURG BED

    MDR report key: 3113476 · Received May 15, 2013

    Report

    Report Number
    0001831750-2013-04403
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 20, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Removal / Correction Number
    RA-2011-070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION ALSO DETERMINED THE FOWLER LOCKOUT LEDS WERE DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SCALE WAS INACCURATE DUE TO LOAD CELL MALFUNCTION AND THE FOWLER LOCKOUT LEDS WERE DAMAGED. 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 THE SCALE WAS INACCURATE DUE TO LOAD CELL MALFUNCTION. 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
    215416 GOBED II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1