BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATEX-OHMEDA S/5 NETWORK AND ICENTRAL

    MDR report key: 5315865 · Received September 24, 2004

    Report

    Report Number
    9610105-2004-00013
    Event Type
    Other
    Date Received
    September 24, 2004
    Date of Event
    August 21, 2004
    Report Date
    August 25, 2004
    Manufacturer
    INSTRUMENTARIUM CORP.
    Product Code
    MSX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MORE INFO WAS ASKED FROM REPORTER, BUT WE HAVE NOT YET RECEIVED. RESULT: CAN NOT BE DETERMINED YET. DATEX-OHMEDA HAS NOT RECEIVED ANY ALLEGATION OR CLAIM THAT THE REPORTED SITUATION CAUSED OR CONTRIBUTED DIRECTLY OR INDIRECTLY TO A DEATH OR SERIOUS INJURY. AT THIS POINT DATEX-OHMEDA CANNOT CONCLUDE WHETHER THE DEVICE FAILED TO MEET ITS PERFORMANCE AND SAFETY SPECIFICATIONS CLAIMED IN THE LABELING. THE FOLLOW-UP REPORT WILL BE SEND AFTER THE INVESTIGATION IS COMPLETED. THIS REPORT IS WRITTEN ENTRIELY WITHOUT PREJUDICE TO ANY OF OUR RIGHTS (AND IS NOT TO BE FOUNDED UPON IN ANY FUTURE COURT PROCEEDINGS).

    Description of Event or Problem · 1

    BARNSLEY CCU, WARD17 & WARD18. INSTALLED: (B)(6) 2004. A) LOSS OF WAVE FORMS ON MULTI-VIEW SCREENS. AFTER A NON SPECIFIC PERIOD OF CONTINUOUS PT MONITORING THE CENTRAL IS LOOSING ECG WAVEFORMS AND FAILING TO ALARM APPROPRIATELY DURING THIS TIME, THE BED SIDE MONITOR CONTINUES AS NORMAL. THERE DOES NOT APPEAR TO BE A CONSISTENT TRIGGER I.E. RETURN FROM STANDBY. ALSO AT THIS TIME FULL DISCLOSURE AND EVENT LOGS ARE LOST. THIS SITUATION AROSE DURING A CRITICAL CHANGE IN A PT'S CONDITION; THE BED SIDE S/5 COMPACT CCM ALARMED VT ON A PT WHO WAS UNDER CENTRAL OBSERVATION FOR CARDIAC ARRYTHMIAS, THE NURSING TEAM ON WARD 17 AWAITED THE SUPPORT OF THE CCU NURSES (I.E. THE ARREST TROLLEY AND DEFIBRILLATOR) WHO SHOULD HAVE BEEN ALERTED BY THE ALARMING CENTRAL AND BEEN ABLE TO ASSESS THE ECG WAVEFORM. NO ALARM OR WAVEFORM WAS VISIBLE, CONNECTION HAD NOT BEEN LOST AS A HEART RATE REMAINED VISIBLE WITH DIGITAL FIELD INFO. B) ON SATURDAY (B)(6) 2004, CLINICAL SPECIALIST WAS CALLED ON TWO OCCASIONS BY STAFF ON THE CORONARY CARE UNIT COMPLAINING THAT THE "CENTRAL HAD CRASHED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA S/5 NETWORK AND ICENTRAL NETWORKING PRODUCTS MSX INSTRUMENTARIUM CORP. L-NET03

    Patients

    Seq Age Sex Outcome Treatment
    1