BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAC-PAK

    MDR report key: 1692177 · Received May 12, 2010

    Report

    Report Number
    2242630-2010-00009
    Event Type
    Other
    Date Received
    May 12, 2010
    Date of Event
    August 1, 2009
    Report Date
    March 6, 2010
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATE NOTIFIED: (B)(6) 2010. A MODEL 1305 ASPIRATOR (S/N (B)(4)) FAILED TO OPERATE TO SPECS. AN INSPECTION OF THE DEVICE REVEALED A DEFECTIVE BATTERY PACK. THE BATTERY PACK 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 VAC-PAK ASPIRATOR BTA IMPACT INSTRUMENTATION, INC. 1305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other