BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA XL

    MDR report key: 2182106 · Received June 23, 2011

    Report

    Report Number
    1220063-2011-00031
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 NUMERICAL READING FOR SPO2 MEASUREMENT DISAPPEARED. AT THE MONITOR, A MASIMO POD WITH MASIMO FINGER SENSOR WAS USED. AFTER A RESET OF THE MONITOR OR AFTER DISCONNECTION AND RECONNECTION OF THE USB PORT, THE MEASUREMENT WORKED AGAIN. THERE WAS NO PT INJURY REPORTED. DRAEGER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) MS18985 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO