BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPACT

    MDR report key: 2439711 · Received January 28, 2012

    Report

    Report Number
    2242630-2010-00066
    Event Type
    Other
    Date Received
    January 28, 2012
    Report Date
    September 25, 2010
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATE NOTIFIED: (B)(4) 2010. A MODEL 305 PORTABLE ASPIRATOR (S/N (B)(4)) FAILED TO OPERATE. AN INSPECTION OF THE DEVICE REVEALED A BATTERY PACK TERMINAL DISCONNECTED. THE TERMINAL WAS RECRIMPED AND RECONNECTED TO THE BATTERY PACK, THE DEVICE WAS TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. 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. 305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other