BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA BED

    MDR report key: 3812535 · Received April 17, 2014

    Report

    Report Number
    1824206-2014-01228
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND THE BED EXIT WILL SET, BUT THE VOLUME WILL NOT CHANGE FROM THE LOW SETTING. HILL-ROM TECHNICAL SUPPORT REPRESENTATIVE SUGGESTED REPLACING THE SIDE RAIL INTERFACE BOARD. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER, IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BED EXIT VOLUME CONTROLS ARE NOT WORKING AND THE VOLUME IS STUCK IN THE LOWEST SETTING. THE BED WAS LOCATED IN THE ED SHOP AT THE FACILITY. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236140 ADVANTA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1600

    Patients

    Seq Age Sex Outcome Treatment
    1