BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPACT

    MDR report key: 2442917 · Received February 3, 2012

    Report

    Report Number
    2242630-2011-00089
    Event Type
    Other
    Date Received
    February 3, 2012
    Report Date
    October 29, 2011
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATE NOTIFIED: (B)(6) 2011. A MODEL 321 PORTABLE ASPIRATOR (SN (B)(4)) FAILED TO OPERATE TO SPECS. AN INSP OF THE DEVICE REVEALED AN INTERMITTENT VACUUM PUMP. THE VACUUM PUMP WAS REPLACED, THE DEVICE WAS TESTED TO SPECS AND RETURNED TO THE CUSTOMER. THE BATTERY PACK, WHICH HAD EXCEEDED IT'S LIFE EXPECTANCY WAS ALSO REPLACED. NO DEATH OR INJURY RESULTED FROM THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT PORTABLE ASPIRATOR BTA IMPACT INSTRUMENTATION, INC. 321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other