BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1961283 · Received December 20, 2010

    Report

    Report Number
    1824206-2010-11760
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN ASKED ACCOUNT TO ISOLATE THE RIGHT HEAD AND LEFT HEAD SIDERAIL CABLES AND SWITCHES. ACCOUNT ORDERED A POWER CONTROL BOARD ASSEMBLY AND SIDERAIL CABLE ASSEMBLIES. NO FURTHER INFORMATION ON THE REPAIR OF THIS BED IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE HI/LOW RUNS UP ON ITS OWN UNTIL THE HI/LOW LOCKOUT IS ACTIVATED. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1