BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA XL

    MDR report key: 2231282 · Received July 25, 2011

    Report

    Report Number
    1220063-2011-00035
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 27, 2011
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATIN THE REPORTED INCIDENT. A F/U REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS BEING MONITORED FOR ATRIAL FIB AND RECEIVING MEDICATION TO CONVERT RHYTHM. THE HEART RATE NOTED ON THE DRAEGER MONITOR SHOWED A RATE OF 98 BUT ACTUAL HEART RATE WHEN REVIEWED MANUALLY WAS 130. THERE WAS NO PT INJURY REPORTED. DRAEGER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) MS18596 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO