BEUDAMED
    FDA Adverse Event Death Summary report: N

    CMS MAIN FRAME

    MDR report key: 1547996 · Received November 20, 2009

    Report

    Report Number
    9610816-2009-00213
    Event Type
    Death
    Date Received
    November 20, 2009
    Date of Event
    June 25, 2007
    Report Date
    November 17, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRT
    PMA / PMN Number
    K00275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE PHILIPS HEALTHCARE RESPONSE CENTER AND REPORTED A PT INCIDENT (DEATH). PT DATA AND THE TIME OF THE PATIENT'S DEATH WERE NOT PROVIDED. THE CUSTOMER REQUESTED TESTING OF THE BEDSIDE MONITOR AND CENTRAL STATION TO VERIFY THAT THE DEVICES WERE OPERATING PROPERLY. NO ALLEGATION OF A DEVICE MALFUNCTION WAS MADE, AND THERE WAS NO ALLEGATION THAT THE DEVICE WAS A CONTRIBUTING FACTOR IN THE INCIDENT. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE POST INCIDENT TO PERFORM DEVICE TESTING. THE FSE TESTED THE BEDSIDE MONITOR AND CENTRAL STATION. BOTH WERE FOUND TO BE OPERATING TO SPECIFICATIONS. ALARMS WERE PROVIDED AT THE BEDSIDE AND CENTRAL STATION AS APPROPRIATE FOR SIMULATED PT CONDITIONS. THE FSE RETRIEVED THE CENTRAL STATION LOG FILES AND ALARM STRIPS FROM THE 07:35 TO 08:00 AM (2007) TIMEFRAME, AND FORWARDED THEM TO THE PHILIPS FACILITY FOR REVIEW. REVIEW OF THE RED LOG SHOWS MULTIPLE BRADYCARDIA AND ASYSTOLIE ALARMS, TWO DESAT ALARMS, AND ONE TACHYCARDIA ALARM IN THE INCIDENT TIMEFRAME. REVIEW OF THE ALARM SUSPEND LOG SHOWS THAT THERE WERE NO ALARM SUSPENSIONS DURING THE INCIDENT TIMEFRAME. REVIEW OF THE ALARM STRIPS SHOWS THAT THE DEVICE RECOGNIZED AND ALARMED FOR THE DETERIORATION OF THE PATIENT'S CONDITION. ASYSTOLIE AND TACHYCARDIA ALARMS ARE NOTED IN THE STRIPS. THE STRIPS ALSO SHOW MISSED AND ARTIFACT BEAT LABELS, AND A BRIEF LEADS OFF INOP CONDITION. THE AVAILABLE DATA SUPPORT THAT THE BEDSIDE MONITOR AND CENTRAL STATION WERE OPERATING PROPERLY AT THE TIME OF THE INCIDENT. THIS IS NOT BEING CONSIDERED A DEVICE MALFUNCTION. THE AVAILABLE INFO DOES NOT INDICATE ANY USER ERROR. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED THE PHILIPS HEALTHCARE RESPONSE CENTER AND REPORTED A PT INCIDENT (DEATH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CMS MAIN FRAME DRT PHILIPS MEDICAL SYSTEMS M1046A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death