BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRATION VENTILATOR SYSTEM

    MDR report key: 593013 · Received April 14, 2005

    Report

    Report Number
    3004023066-2005-00003
    Event Type
    Malfunction
    Date Received
    April 14, 2005
    Date of Event
    March 10, 2005
    Report Date
    March 15, 2005
    Manufacturer
    EVENT MEDICAL LTD
    Product Code
    CBK
    Removal / Correction Number
    300402366-8/12/05-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BURNING INSIDE THE VENTILATOR ENCLOSURE WHICH CAUSED DAME TO THE PNEUMATIC BLOCK ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRATION VENTILATOR SYSTEM VENTILATOR CBK EVENT MEDICAL LTD INSPIRATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN