BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPACT VAC-PAK

    MDR report key: 93540 · Received May 23, 1997

    Report

    Report Number
    2242630-1997-00001
    Event Type
    Death
    Date Received
    May 23, 1997
    Date of Event
    April 12, 1997
    Report Date
    May 22, 1997
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DISTRIBUTOR ADVISED IMPACT THAT A MODEL 1305 VAC-PAK SUCTION UNIT WAS BEING RETURNED FOR REPAIR. THE USER HAD ADVISED THEM THAT THE EQUIPMENT HAD FAILED TO OPERATE WHEN USED ON A PATIENT AND THAT THE PATIENT EVENTUALLY HAD DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT VAC-PAK SUCTION (PORTABLE) BTA IMPACT INSTRUMENTATION, INC. 1305 0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death