BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE

    MDR report key: 1171928 · Received September 19, 2008

    Report

    Report Number
    1824206-2008-03497
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED EMAIL FROM HILL-ROM REGIONAL SALES MANAGER STATING THAT HE HAS BEEN INFORMED THAT THE TWO NEW LOAD BEAMS, AND THE NEW SCALE PC BOARD HAVE BEEN INSTALLED AND THE SCALE IS NOW FUNCTIONING PROPERLY. THIS RESOLVED THE ISSUE OF THE SCALE NOT WEIGHING PROPERLY.

    Description of Event or Problem · 1

    RECEIVED EMAIL FROM CUSTOMER STATING THAT THE SCALE IS NOT WEIGHING PROPERLY. HE STATED THAT THE WEIGHT IS RANDOMLY OFF 3 TO 7 KG UP OR DOWN EVERY TIME. HE CONFIRMED THAT THE PACKING SHIMS HAVE BEEN REMOVED. HE CLAIMED THAT P1 RED LED IS LIT ON THE SCALE PC BOARD AND HE SWAPPED P1 AND P2 CONNECTORS AND P1 REMAINED LIT. HE ALSO STATED THAT THE SCALE IS DISPLAYING ERR3. I ASKED HIM TO CHECK THE WEIGHT FRAME TO SEE IF IT IS BENT. HE CLAIMS THAT IT IS NOT BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE AC POWERED HOSPITAL BED FNL HILL-ROM RITTER P3200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1