BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPACT SUCTION DEVICE

    MDR report key: 1692181 · Received May 12, 2010

    Report

    Report Number
    2242630-2010-00015
    Event Type
    Other
    Date Received
    May 12, 2010
    Date of Event
    February 4, 2010
    Report Date
    March 20, 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)(6) 2010. A MODEL 305 ASPIRATOR (S/N (B)(4)) FAILED TO OPERATE ON HIGH SPEED. AN INSPECTION OF THE DEVICE REVEALED A BATTERY PACK TERMINAL WAS DISCONNECTED. THE TERMINAL WAS RE-CRIMPED AND RECONNECTED TO THE BATTERY PACK, 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. 305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other