BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE FRAME

    MDR report key: 3061347 · Received March 26, 2013

    Report

    Report Number
    1824206-2013-01694
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECH SUPPORT SUGGESTED THE CUSTOMER REPLACED THE HEAD UP VALVE. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN RESOLUTION, HOWEVER, NO OTHER INFO HAS BEEN OBTAINED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATED THE HEAD SECTION WOULD NOT RAISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123167 TOTALCARE FRAME AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1