BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELTA XL

    MDR report key: 2151482 · Received June 23, 2011

    Report

    Report Number
    1220063-2011-00029
    Event Type
    Other
    Date Received
    June 23, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 23, 2011
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    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 PT IN THE OPERATING ROOM FOR SQ PORT REPLACEMENT (RIGHT). SUPINE POSITION, TEMP PROBE POSITIONED IN RIGHT AXILLA (WITHOUT COVER). RIGHT ARM TUCKED. PREPPED CHEST AND NECK AREA WITH CHLORHEXIDINE 4%. CAUTERY USED DURING PROCEDURE. BURN NOTED NEXT MORNING. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other NO