BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPACT

    MDR report key: 2450928 · Received February 3, 2012

    Report

    Report Number
    2242630-2011-00113
    Event Type
    Other
    Date Received
    February 3, 2012
    Report Date
    December 31, 2011
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATE NOTIFIED: (B)(6) 2011 A MODEL 324 ON-BOARD ASPIRATOR (S/N (B)(4)) FAILED TO OPERATE. AN INSPECTION OF THE DEVICE REVEALED A DEFECTIVE DIODE. THE DIODE WAS REPLACED, 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 ON-BOARD ASPIRATOR BTA IMPACT INSTRUMENTATION, INC. 324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other