BEUDAMED
    FDA Adverse Event Other Summary report: N

    SC7000

    MDR report key: 1416822 · Received July 17, 2009

    Report

    Report Number
    1220063-2009-00019
    Event Type
    Other
    Date Received
    July 17, 2009
    Date of Event
    April 30, 2009
    Report Date
    July 17, 2009
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    K031433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO SIMILAR COMPLAINTS FILED WITHIN THE COMPLAINT DATABASE. THE ALARM SETTINGS THAT WERE SUBMITTED BY THE COMPLAINANT ARE DATED FROM (B) (6) (FOUR DAYS AFTER THE EVENT). THE CUSTOMER STATES THE MONITOR HAS BEEN SEQUESTERED SINCE THE DATE OF THE EVENT WHEN THESE PRINTOUTS WERE TAKEN. THE ALARMS SETTING FROM (B) (6)2009, INDICATE THAT THE VT ALARM WAS SET UNDER THE PARAMETER OF A LIFE-THREATENING ALARM. THERE WERE NO ALARM LOGS CAPTURED RELATED TO THE DATE OF THE EVENT. THE ROOT CAUSE FOR A MONITOR TO POST WITH AN ALARM LEVEL OTHER THAN WHAT IT WAS INTENDED AS CONFIGURED BY THE USER IS UNDETERMINED. ADD'L INFO TO COMPLETE AN INVESTIGATION WAS NOT MADE AVAILABLE. ACCORDING TO THE COMPLAINANT, THE CITED MONITOR WAS TESTED AND FUNCTIONS AS PER MFR'S SPECS. THE MONITOR HAS BEEN RETURNED TO THE CUSTOMER AND IS FUNCTIONING WITH NO FURTHER RELATED ISSUES REPORTED. NO ACTIONS ARE PLANNED BY THE MFR AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS OF THIS CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONITOR DID NOT ALARM AS EXPECTED WHEN THE PT HAD VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO REPORTED THAT THE MONITOR ALARMED CORRECTLY WHEN THE PT HAD VENTRICULAR FIBRILLATION (VF). IT WAS REPORTED THAT A PT WAS INJURED, BUT THE EXTENT OF THE INJURY IS UNK. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SC7000 PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other