BEUDAMED
    FDA Adverse Event Other Summary report: N

    VEST

    MDR report key: 661554 · Received January 4, 2006

    Report

    Report Number
    1045510-2006-00003
    Event Type
    Other
    Date Received
    January 4, 2006
    Report Date
    December 12, 2005
    Manufacturer
    HILL-ROM CHARLESTON
    Product Code
    BYI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MALE WAS A TERM NEWBORN WITH MECONIUM ASPIRATION SYNDROME REQUIRING ECMO. HE SUFFERED AN ANOXIC EVENT DUE TO PROLONGED HYPOXEMIA AND CONSEQUENTIAL CEREBRAL PALSY, SEVERE DEVELOPMENTAL DELAY AND SEIZURES. HIS FIRST PULMONARY EVALUATION OCCURRED AT 14 MONTHS OF AGE. MANUAL CPT WAS BEING PERFORMED AT THE TIME. THE PRIMARY CARE PHYSCIAN ORDERED A VEST SYSTEM AT 4 YEARS. AT A PULMONARY VISIT 3 MONTHS FOLLOWING INITIATION OF VEST THERAPY, THE PARENTS INDICATED THE PATIENT WAS HAVING CLEARANCE ISSUES WITH THE SECRETIONS LOOSENED BY THE VEST. A MI-E WAS PRESCRIBED AND IS NOW USED IN CONJUNCTION WITH THE VEST WITHOUT SECRETION PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEST POWERED PERCUSSOR BYI HILL-ROM CHARLESTON 104 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other