BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA XL

    MDR report key: 3770424 · Received March 6, 2014

    Report

    Report Number
    1220063-2014-00008
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    December 28, 2013
    Report Date
    February 17, 2014
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS MONITORED WITH DELTA XL IN CCU AND JUST AS THE PATIENT GOT A FAST CARDIAC ARRYTHMIA EVENT, THE DELTA XL REBOOTED ITSELF AND THE PATIENT WAS NOT MONITORED FOR MORE THAN ONE MINUTE. THERE WAS NO PATIENT INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136842 DELTA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO