BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HR 1000

    MDR report key: 3130462 · Received March 27, 2013

    Report

    Report Number
    3006697241-2013-00065
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Manufacturer
    HILL-ROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT DID NOT KNOW EXACTLY WHICH BED WAS INVOLVED IN THE EVENT. AN ACCOUNT EXECUTIVE AND FIELD SERVICE TECHNICIAN INSPECTED SEVERAL BEDS AT THE FACILITY AND WERE ABLE TO POP THE BRAKE OUT OF THE LOCKED MODE. UPON FURTHER INVESTIGATION, HILL-ROM ENGINEERING DETERMINED THAT THE CASTER CAM IS NOT ROTATING SUFFICIENTLY SO THAT IT PROPERLY LOCKS IN BRAKE POSITION WHEN THE FOOT END BRAKE PEDAL IS ACTIVATED. THE BRAKE POSITION WHEN THE FOOT END BRAKE PEDAL IS ACTIVATED. THE BRAKE ENGAGEMENT OF THE CASTER CAM AT THE HEAD END OF THE BED IS ALSO AFFECTED BY THE LOSS IN THE TRANSMISSION OF ANGULAR DISPLACEMENT FROM THE FOOT END BRAKE MECHANISM.

    Description of Event or Problem · 1

    REFERENCE TO IMPORTER REPORT # 1824206-2013-01721.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127307 HR 1000 AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM DE MEXICO S DE RL DE CV

    Patients

    Seq Age Sex Outcome Treatment
    1