BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA XL

    MDR report key: 2785794 · Received October 3, 2012

    Report

    Report Number
    1220063-2012-00060
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 2, 2012
    Report Date
    September 3, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 THE MONITOR GENERATED A BRADYCARDIA ALARM ON BED 7 ON (B)(6) 2012 BETWEEN 16:00 AND 18:00. THE STAFF DID NOT KNOW THE EXACT TIME. WHEN THE NURSE WENT TO THE BED, THE INFANT WAS BLUE IN THE FACE BUT THE MONITOR SHOWED AN SAO SATURATION OF 100%. AN SAO ALARM REPORTEDLY DID NOT OCCUR. THE LOGS WERE SAVED, BUT LONG-TERM DATA IS GONE BECAUSE OF THE MONITOR CHANGE. AT THE TIME OF THE EVENT, THE STAFF DID NOT KNOW THE DISEASE OF THE INFANT. THE ONLY THING THE STAFF KNOWS IS THAT THE INFANT OFTEN FORGETS TO BREATHE. THERE WAS NO PT INJURY REPORTED. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO