BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISTA XL

    MDR report key: 2151495 · Received June 23, 2011

    Report

    Report Number
    1220063-2011-00030
    Event Type
    Other
    Date Received
    June 23, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 24, 2011
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    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 THERE IS NO CUSTOMER DIRECT ALLEGATION ABOUT AN INJURY INDUCED BY A DRAEGER DEVICE TO THE PT. THE CUSTOMER WANTS TO FIND OUT THE CAUSE OF THE INJURIES INDUCED TO 4 PATIENTS BY A DEVICE IN THE OPERATING ROOM. THE INJURIES OBSERVED ARE "DEEP BURN INJURIES" EXACTLY UNDER THE PLACE OF THE SKIN ELECTRODES FOR ECG (CONNECTED BY LEADS TO THE INFINITY VISTA MONITOR). IT WAS FURTHER REPORTED THAT THE INCIDENTS ARE RELATED TO AN ELLMANN INT INC ELECTRO-CAUTERY DEVICE THAT WAS USED IN THE OPERATING ROOM IN THESE 4 CASES. DRAEGER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA XL PATIENT MONITOR MHX DRAGER MEDICAL SYSTEMS, INC. (IT/M) MS18986 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other NO