BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRATION VENTILATOR SYSTEM

    MDR report key: 593079 · Received April 14, 2005

    Report

    Report Number
    3004023066-2005-00004
    Event Type
    Malfunction
    Date Received
    April 14, 2005
    Date of Event
    September 8, 2003
    Report Date
    January 24, 2005
    Manufacturer
    EVENT MEDICAL LTD
    Product Code
    CBK
    Removal / Correction Number
    3004023066-8/12/05-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT FROM THE CUSTOMER INDICATED NO FLOW AND HIGH PRESSURE WITHIN THE TANK IN SPITE OF THE TANK BEING EMPTY. NO PHYSICAL OR ELECTRICAL DAMAGE TO THE INTERNAL PRINTED CIRCUIT BOARDS. CUSTOMER ALSO REPORTED THERMAL DAMAGE 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 NA