BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA XL

    MDR report key: 3925173 · Received June 26, 2014

    Report

    Report Number
    1220063-2014-00023
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 WHILE IN USE, THE DISPLAY WENT BLACK AND THE ALARM LENS ON THE TOP OF THE MONITOR BEGAN FLASHING RED. THE MONITOR WAS SWAPPED OUT AND THERE WAS NO PT INJURY REPORTED. A DRAGER SERVICE TECHNICIAN WAS DISPATCHED AND WAS ABLE TO CONFIRM THE REPORTED SYMPTOM. THE TECHNICIAN REPLACED THE DC/AC INVERTER. THE MONITOR WAS TESTED AFTER THE REPAIR AND ALL TESTS REPORTEDLY PASSED. THE MONITOR HAS BEEN RETURNED TO USE WITH NO FURTHER PROBLEMS REPORTED. DRAEGER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373842 GAMMA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS18985 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO