BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPACT SUCTION DEVICE

    MDR report key: 1692179 · Received May 12, 2010

    Report

    Report Number
    2242630-2010-00010
    Event Type
    Other
    Date Received
    May 12, 2010
    Report Date
    March 6, 2010
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATE NOTIFIED: (B)(6) 2010. A MODEL 326 ASPIRATOR (S/N (B)(4)) FAILED TO OPERATE TO SPECS. AN INSPECTION OF THE DEVICE REVEALED A DEFECTIVE CIRCUIT BREAKER. THE CIRCUIT BREAKER WAS REPLACED, THE DEVICE WAS TESTED TO SPECS AND RETURNED TO THE CUSTOMER. NO PT WAS INVOLVED AT THE TIME OF THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT SUCTION DEVICE ASPIRATOR BTA IMPACT INSTRUMENTATION, INC. 326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other