BEUDAMED
    FDA Adverse Event Death Summary report: N

    VEST, MODEL 205

    MDR report key: 1224928 · Received November 10, 2008

    Report

    Report Number
    1045510-2008-00022
    Event Type
    Death
    Date Received
    November 10, 2008
    Date of Event
    September 10, 2008
    Report Date
    November 10, 2008
    Manufacturer
    HILL-ROM MANUFACTURING, INC.
    Product Code
    BYI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATION OF A MALFUNCTION OF THE UNIT WAS RECEIVED BY HILL-ROM. THE UNIT IS CURRENTLY BEING RETURNED TO HILL-ROM FOR A FORMAL ANALYSIS TO ENSURE THE UNIT IS OPERATING PROPERLY.

    Description of Event or Problem · 1

    HILL-ROM HAS RECEIVED A REPORT THAT ALLEGES THE VEST MAY HAVE CONTRIBUTED TO A PT'S DEATH. THE REPORT STATES THAT THE PT'S CONDITION WORSENED TWO HOURS AFTER VEST TREATMENT WHEN THE PT BEGAN TO "COUGH UP LARGE AMOUNTS OF THICK, BROWNISH, CHUNKY SPUTUM." THE PT DIED THE NEXT DAY. THE PT HAS A HISTORY OF ESOPHAGEAL STRICTURE, ARTHRITIS, GASTROESOPHAGEAL REFLUX DISEASE, HYPERPARATHYROIDISM, SHINGLES, SCOLIOSIS, GASTROINTESTINAL BLEEDING, PERFORATED PEPTIC ULCER AND INTESTINAL ADHESIONS ACCORDING TO THE HOSPITAL'S HISTORY AND PHYSICAL REPORT. NO ALLEGATION OF A MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEST, MODEL 205 POWERED PERCUSSOR BYI HILL-ROM MANUFACTURING, INC. 205

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death