BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENT 201

    MDR report key: 1931764 · Received November 22, 2010

    Report

    Report Number
    9616775-2010-00006
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 22, 2010
    Manufacturer
    VERSAMED MEDICAL SYSTEMS LTD.
    Product Code
    CBK
    PMA / PMN Number
    K073694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE DECLINED TO PROVIDE PATIENT INFO TO GE HEALTHCARE.

    Description of Event or Problem · 1

    A SITE REPORTED THAT THE UNIT SHUT DOWN AND DID NOT ALARM. NO INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVENT 201 VENTILATOR, CONTINUOUS, FACILITY USE CBK VERSAMED MEDICAL SYSTEMS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1