BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEST MODEL 105

    MDR report key: 1662356 · Received April 16, 2010

    Report

    Report Number
    1045510-2010-00005
    Event Type
    Injury
    Date Received
    April 16, 2010
    Date of Event
    March 15, 2010
    Report Date
    March 18, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    BYI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SERVES AS AN INITIAL REPORT; A FOLLOW UP REPORT WILL BE SENT TO THE FDA AS SOON AS THE UNIT IS RETURNED AND THE UNIT IS EVALUATED.

    Description of Event or Problem · 1

    HILL-ROM IS FILLING A CONSERVATIVE REPORT TO THE FDA: HILL-ROM HAS RECEIVED AN ALLEGATION THAT SUGGESTS A PATIENT SUFFERED HEMORRHAGES IN BOTH EYES AFTER A WEEK OF TREATMENT WITH THE VEST AIRWAY CLEARANCE THERAPY. THE PATIENT HAD HEMORRHAGES IN BOTH EYES WHEN FIRST BORN, HAS HYPERTROPHIC CARDIOMYOPATHY, HIP DYSPLASIA, CANNOT WALK OR TALK, HAS A RARE DISORDER (B) (6), AND IS A 3 YEAR CANCER SURVIVOR. TREATMENTS HAVE BEEN STOPPED. THE DR IS UNSURE OF THE CAUSE OF THE HEMORRHAGES. NO ALLEGATION OF A MALFUNCTION HAS BEEN ALLEGED, AND THE UNIT HAS NOT YET BEEN RETURNED TO HILL-ROM FOR EVALUATION. THIS MDR SERVES AS AN INITIAL REPORT; A FOLLOW UP REPORT WILL BE SENT TO THE FDA AS SOON AS THE UNIT IS RETURNED AND THE UNIT IS EVALUATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other