BEUDAMED
    FDA Adverse Event Other Summary report: N

    VEST MODEL 105

    MDR report key: 2162279 · Received July 8, 2011

    Report

    Report Number
    3008145987-2011-00004
    Event Type
    Other
    Date Received
    July 8, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 8, 2011
    Manufacturer
    HILL-ROM SERVICES PRIVATE LIMITED
    Product Code
    BYI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED AND EVALUATED - NO MALFUNCTION WAS ALLEGED NOR FOUND THROUGH THE ANALYSIS.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT ALLEGING THAT THE PATIENT'S RIB DISLOCATED AFTER VEST TREATMENT. THE PATIENT INDICATED THAT THE RIBS WOULD HEAL ON THEIR OWN, AND LATER STATED THAT THE RIBS HAVE PROBABLY HEALED BY NOW. THE UNIT WAS RETURNED AND EVALUATED - NO MALFUNCTION WAS ALLEGED NOR FOUND THROUGH THE ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other