BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEST MODEL 105

    MDR report key: 1031257 · Received April 18, 2008

    Report

    Report Number
    1045510-2008-00001
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 16, 2008
    Report Date
    April 18, 2008
    Manufacturer
    HILL-ROM CHARLESTON
    Product Code
    BYI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HILL-ROM MANUFACTURING, INC. HAS RECEIVED A REPORT THAT REASONABLY SUGGESTS THAT THE VEST MAY HAVE CONTRIBUTED TO A PATIENT'S RIB FRACTURE. NO MALFUNCTION OF THE UNIT WAS ALLEGED. THE PATIENT HAS OSTEOPOROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEST MODEL 105 POWERED PERCUSSOR BYI HILL-ROM CHARLESTON 105

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention