BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPACT

    MDR report key: 1346796 · Received March 16, 2009

    Report

    Report Number
    2242630-2009-00006
    Event Type
    Other
    Date Received
    March 16, 2009
    Date of Event
    February 3, 2008
    Report Date
    March 7, 2009
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATE NOTIFIED: 2/28/08. A MODEL 324 ON-BOARD ASPIRATOR (B) (4) FAILED TO PROVIDE SUFFICIENT VACUUM. AN INSPECTION OF THE DEVICE REVEALED A DEFECTIVE TORN PUMP DIAPHRAGM. THE DIAPHRAGM WAS REPLACED, THE DEVICE WAS TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. NO PATIENT WAS INVOLVED AT THE TIME OF THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT ON-BOARD ASPIRATOR BTA IMPACT INSTRUMENTATION, INC. 324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other