BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEST MODEL 105

    MDR report key: 2895346 · Received November 1, 2012

    Report

    Report Number
    3008145987-2012-00004
    Event Type
    Injury
    Date Received
    November 1, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 9, 2012
    Manufacturer
    HILLROM SERVICES PRIVATE LIMITED
    Product Code
    BYI
    PMA / PMN Number
    K024309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    HILL-ROM RECEIVED AND REPORT THAT REASONABLY SUGGESTED THAT THE VEST MAY HAVE CONTRIBUTED TO A COLLAPSED LUNG. THE UNIT WAS EVALUATED AND NO PROBLEM WAS FOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization