BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENT 201

    MDR report key: 2001534 · Received January 26, 2011

    Report

    Report Number
    9616775-2011-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    August 10, 2010
    Report Date
    January 26, 2011
    Manufacturer
    VERSAMED MEDICAL SYSTEMS, LTD.
    Product Code
    CBK
    PMA / PMN Number
    K073694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SITE REPORTEDLY NOTED A PATIENT REMOVING THE IVENT 201 MASK FROM THEIR FACE. THE SITE FURTHER REPORTED THE UNIT WAS NOT VENTILATING, AND A BURNING SMELL WAS NOTED. THERE WAS NO REPORTED PATIENT INJURY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1