BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE VEST AIRWAY CLEARANCE SYSTEM

    MDR report key: 507158 · Received January 16, 2004

    Report

    Report Number
    2183816-2004-00001
    Event Type
    Injury
    Date Received
    January 16, 2004
    Date of Event
    December 3, 2003
    Report Date
    January 15, 2004
    Manufacturer
    HILL-ROM MANUFACTURING, INC.
    Product Code
    BYI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT'S FAMILY MEMBER REPORTS PT COMPLAINED OF "BAD HEADACHES" AFTER DOING VEST TREATMENTS. THE HEADACHES CONTINUED FOR TWO WEEKS. PT DEVELOPED SLURRED SPEECH AFTER TREATMENT. PT WAS TAKEN TO DR. FOR AN MRI. MRI CONFIREMD PT HAD SWELLING OF NECK TISSUE AND HAD A SMALL STROKE. DR. FELT SWELLING EFFECTED BLOOD FLOW TO HEAD AND THE VEST MIGHT HAVE CONTRIBUTED TO THE SWELLING IN SOME WAY. DR. COULD NOT RULE OUT A PRE-EXISTING CONDITION EFFECTING THE CIRCULATION IN PT'S NECK. VEST TREATMENTS DISCONTINUED, PT STARTED ON CORTISONE AND ASPIRIN. AT THIS TIME, SWELLING IN THE NECK IS REDUCED, PT IS OFF CORTISONE AND HAD REGAINED SPEECH. DEVICE WILL BE SHIPPED BACK FOR TESTING. ACCOUNT MANAGER SPOKE WITH PT IN 2003 VERIFYING EVENTS DESCRIBED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE VEST AIRWAY CLEARANCE SYSTEM POWERED PERCUSSOR BYI HILL-ROM MANUFACTURING, INC. 104 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention