BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOBED II

    MDR report key: 3612556 · Received February 7, 2014

    Report

    Report Number
    0001831750-2014-01073
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 10, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO REPORT THAT AN INSPECTION WAS SAID TO HAVE BEEN PERFORMED BY AN UNKNOWN INDIVIDUAL AT SANTA CASA DE SAO PAULO. IT WAS FURTHER REPORTED THAT THE TECHNICAL ASSISTANCE DEPARTMENT HAS FIXED THE BED AND IT IS BACK IN SERVICE. INSPECTION WAS PERFORMED BY AN UNKNOWN INDIVIDUAL AT (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD END OF THE BED DECLINED ABRUPTLY (APPROXIMATELY 50CM) DUE TO A MALFUNCTIONED LIFT MOTOR. THE PATIENT ON THE BED WAS REPORTEDLY "VERY SCARED AND HAS PSYCHOLOGICAL DAMAGES."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD END OF THE BED DECLINED ABRUPTLY (APPROXIMATELY 50CM) DUE TO A MALFUNCTIONED LIFT MOTOR. THE PATIENT ON THE BED WAS REPORTEDLY "VERY SCARED AND HAS PSYCHOLOGICAL DAMAGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80321 GOBED II BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1