BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R50N RECORDER

    MDR report key: 2182112 · Received June 23, 2011

    Report

    Report Number
    1220063-2011-00033
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 24, 2011
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    DSI
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 DURING USE, THE R50 RECORDER STARTED TO SMOKE WHILE IT WAS SITTING ON TOP OF AN APOLLO ANESTHESIA MACHINE DURING A CASE. THERE WAS NO PT INJURY REPORTED. DRAEGER REFERENCE NUMBER; (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R50N RECORDER BEDSIDE RECORDER DSI DRAEGER MEDICAL SYSTEMS, INC. (IT/M) 5952630 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO