BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE

    MDR report key: 1163378 · Received September 10, 2008

    Report

    Report Number
    1824206-2008-03370
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECH INSPECTED THE BED AND CHECKED OUT FINE, PENDANT WAS CHANGED AND IT WAS NOT AVAILABLE FOR INSPECTION. HILL-ROM TECH AND UNIT MGR SPOKE WITH THE PT INVOLVED IN THE EVENT. THE PT ALLEGED THAT SHE PINCHED HER FINGER ON THE PT PENDANT AND WAS NOT SHOCKED AS ORIGINALLY REPORTED. THE PT REPORTED THAT THE STRAIN RELIEF HAD SEPARATED FROM THE PT PENDANT BODY AND THIS IS WHERE SHE PINCHED HER FINGER. SHE ALSO STATED THAT SHE WAS NOT INJURED. ALSO THERE WAS NO TREATMENT PROVIDED.

    Description of Event or Problem · 1

    A HILL-ROM TECHNICAL SUPPORT REP CALLED AND SAID, HE RECEIVED A CALL FROM ACCOUNT ALLEGING THAT A PT RECEIVED A SHOCK FROM PT PENDANT.

    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