BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA - ZONEAIRE W/SCALE & P ADVANTA FRAME

    MDR report key: 1662167 · Received April 12, 2010

    Report

    Report Number
    1824206-2010-05515
    Event Type
    Malfunction
    Date Received
    April 12, 2010
    Date of Event
    June 7, 2007
    Report Date
    June 7, 2007
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REPLACED THE UNIVERSAL TELEVISION JUNCTION BOARD, WHICH RESOLVED THE ISSUE. THE DEVICE FUNCTIONS AS DESIGNED. PURSUANT TO OUR RESPONSE TO WARNING LETTER 2008-DT-04, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT THE NURSE CALL SYSTEM WILL NOT SEND A SIGNAL TO THE NURSES' STATION. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTA - ZONEAIRE W/SCALE & P ADVANTA FRAME A/C POWERED HOSPITAL BED FNL HILL-ROM RITTER P1600A6037

    Patients

    Seq Age Sex Outcome Treatment
    1