BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPACT MODEL 305

    MDR report key: 1631232 · Received March 8, 2010

    Report

    Report Number
    2242630-2010-00005
    Event Type
    Other
    Date Received
    March 8, 2010
    Report Date
    February 6, 2010
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    JCX
    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. AN INSPECTION OF THE DEVICE REVEALED A DEFECTIVE VACUUM PUMP. THE VACUUM PUMP WAS REPLACED, THE DEVICE WAS TESTED TO SPECS AND RETURNED TO THE CUSTOMER. NO DEATH OR INJURY RESULTED FROM THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT MODEL 305 PORTABLE ASPIRATOR JCX IMPACT INSTRUMENTATION, INC. 305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other