BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPACT

    MDR report key: 2162047 · Received April 5, 2010

    Report

    Report Number
    2242630-2011-00012
    Event Type
    Other
    Date Received
    April 5, 2010
    Report Date
    February 5, 2011
    Manufacturer
    IMPACT INSTRUMENTATION, INC
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATE NOTIFIED: (B)(6) 2011. A MODEL 326 PORTABLE ASPIRATOR (S/N (B)(4)) FAILED TO OPERATE. AN INSPECTION OF THE DEVICE REVEALED A DEFECTIVE COMPRESSOR WIRE TERMINAL. THE TERMINAL WAS REPLACED, THE DEVICE WAS TESTED TO SPECS 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 326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other