BEUDAMED
    FDA Adverse Event Other Summary report: N

    IVENT201

    MDR report key: 1655109 · Received April 7, 2010

    Report

    Report Number
    9616775-2010-00001
    Event Type
    Other
    Date Received
    April 7, 2010
    Date of Event
    February 1, 2010
    Report Date
    April 6, 2010
    Manufacturer
    VERSAMED MEDICAL SYSTEMS LTD.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    LOANER SERIAL (B)(4). MAGNET IS PULLING UNIT SMELLED HOT BURNING SMELL, WHEN THEY TRIED TO CONNECT IT TO A PATIENT. THEY WANT TO KNOW IF IT'S MRI COMPATIBLE" NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVENT201 PORTABLE VENTILATOR CBK VERSAMED MEDICAL SYSTEMS LTD. 1.4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1