BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA

    MDR report key: 1891387 · Received November 3, 2010

    Report

    Report Number
    1220063-2010-00053
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Report Date
    June 11, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRINTSCREENS FROM THE GAMMA MONITOR WERE AVAILABLE FROM THE DATE OF EVENT, (B)(6)2010. THE LOGS DRAEGER RECEIVED FROM THE MULTIVIEW WORKSTATION AND IDS DO NOT INDICATE ANY ALARM LIMIT CHANGES WITH THE BEDSIDE MONITOR. THE ROOT CAUSE IS UNKNOWN. THE BIOMED DEPARTMENT OF THE HOSPITAL AND THE DRAGER SERVICE CHECKED THE MONITORS BUT COULD NOT FIND A FAILURE. THERE HAVE BEEN NO REPORTED INCIDENCES OF PT MONITOR ALARM SETTING CHANGES WITHOUT USER INPUT. NO ACTIONS ARE PLANNED BY DRAEGER AT THIS TIME. DRAEGER WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS BY THIS CONDITION.

    Description of Event or Problem · 1

    BASED ON THE RESULTS OF A SIMILAR INVESTIGATION (MDR 1220063-2010-00050/(B)(4)), THIS COMPLAINT IS NOW DETERMINED TO BE REPORTABLE. IT WAS REPORTED THAT THE ALARM LIMITS CHANGED SPORADICALLY WITHOUT ANY EFFORT AND THAT AFTER DISCHARGING OF PATIENTS, ALL ALARM LIMITS EXCEPT ECG SWITCHED OFF PARTLY. THE BIOMED DEPARTMENT OF THE HOSPITAL AND DRAEGER SERVICE CHECKED THE MONITORS BUT COULD NOT FIND A FAILURE. THERE WAS NO PT INJURY REPORTED. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO