BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTIGAS MONITOR

    MDR report key: 1020376 · Received March 28, 2008

    Report

    Report Number
    2520313-2008-00005
    Event Type
    Death
    Date Received
    March 28, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 28, 2008
    Manufacturer
    MEDRAD, INC.
    Product Code
    CCK
    PMA / PMN Number
    K983250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE ANALYSIS FOR THE RETURNED PRODUCTS HAS NOT BEEN COMPLETED. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    HOSP REPORTED A PT WAS SCHEDULED FOR A CERVICAL SPINE MRI DUE TO A SPINAL FRACTURE. THE PT WAS AN IN-PT FROM A MONITORED UNIT. THE PT WAS MOVED TO THE SCANNER AND THE TECHNOLOGIST ATTEMPTED TO HOOK HIM UP TO THE PULSE OXIMETER ON THE 9500 MONITOR AND IT WAS WORKING INTERMITTENTLY. THERE WAS ENOUGH STAFF PRESENT SO THAT ONE PERSON WAS ABLE TO STAY WITH THE PT DURING THE PROCEDURE. THEY PLACED A CUP ON THE PT'S CHEST IN ORDER TO MONITOR RESPIRATIONS. AFTER APPROX 10 MINUTES OF SCANNING, THE TECHNOLOGIST NOTICED THAT THE CUP WAS NOT MOVING. THE PT WAS REMOVED FROM THE SCANNER AND AN ASSESSMENT OF THE PT DETERMINED HE WAS NOT BREATHING. THE PT WAS MOVED FROM THE SCANNER AND A CODE WAS CALLED. THE PT THEN EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIGAS MONITOR MULTIGAS MONITOR CCK MEDRAD, INC. 9500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death