BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3150 INFO CNTR LOCAL DATABASE REL M.0

    MDR report key: 6112097 · Received November 18, 2016

    Report

    Report Number
    1218950-2016-07256
    Event Type
    Death
    Date Received
    November 18, 2016
    Date of Event
    October 23, 2016
    Report Date
    October 24, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THERE WAS NO MALFUNCTION. THE BIOMEDICAL ENGINEER WANTED ALL INFORMATION FROM THE LOGS AVAILABLE FROM 8PM TO 10PM FOR BED 918B (TEL30) ON (B)(6) 2016. PER PATIENT SAFETY OFFICER, THE PATIENT WAS USING A DUAL CHAMBER PACEMAKER AND HAD BEEN EXPERIENCING ABDOMINAL PAIN. THE ISSUE WAS THAT THERE WAS A DELAY IN RECOGNIZING THE PATIENT¿S CONDITION AND IN PROVIDING TREATMENT. PER PATIENT SAFETY OFFICER THE PATIENT CODED AT 22:00PM AND EXPIRED AT 22:22PM. THE PIIC ALARM LOGS AND SYSTEM LOGS WERE SENT TO PHILIPS R&D FOR ANALYSIS. THE LOGS SHOW THAT THE PIIC DEVICE DID ALARM AS A RED V-TACH ALARM FOR THE TIME IN QUESTION (21:59:49.843 (B)(6) 2016) AND SUPPORTS THAT THE DEVICE WAS MONITORING AND ANNUNCIATING ALARMS PER SPECIFICATIONS. THERE WERE NO PATIENT ALARMS PRIOR TO 21:59 ON THAT DAY ((B)(6) 2016). THE LOGS TAKEN FROM THE DEVICE HAD WRAPPED, MEANING THAT DUE TO THE PASSAGE OF TIME SINCE THE EVENT, NOT ALL RELEVANT LOG DATA WAS STILL PRESENT, THEREFORE R&D COULD NOT GIVE MORE INFORMATION ON THE DEVICE. HOWEVER, R&D STATED THAT THE PATIENT ADMIT STATE DIDN'T CHANGE, THEY STAYED IN THE SAME BED ASSIGNMENT, AND DATA WAS BEING COLLECTED FOR THE BED FOR HOURS BEFORE THE EVENT. BASED ON THE INFORMATION PROVIDED THERE IS NO DATA TO SUPPORT A MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS AN ADVERSE PATIENT EVENT AND THE NURSE STAFF ALLEGED THAT THE CENTRAL STATION MONITOR DID NOT ALARM. THE DATE OF THE ADVERSE EVENT WAS (B)(6) 2016 BETWEEN 9:55 AND 10:03PM FOR BED 918B. THE CUSTOMER WAS ALSO CONCERNED THE MONITOR WAS READING ARTIFACT AS A RHYTHM AND THE STAFF THOUGHT THAT WAS WHY THEY DID NOT NOTICE THE PATIENT CONDITION. INVESTIGATION IS REQUIRED GOING FORWARD TO REVIEW THE PIIC ALARM LOGS AND THE PATIENT STRIPS TO ASCERTAIN WHETHER THE PHILIPS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. THE PATIENT WAS BEING MONITORED AT THE CENTRAL STATION INFORMATION CENTER. THE PATIENT WAS USING A DUAL CHAMBER PACEMAKER AS SEEN FROM THE PATIENT STRIPS. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765471 M3150 INFO CNTR LOCAL DATABASE REL M.0 M3150 INFO CNTR LOCAL DATABASE REL M.0 MHX PHILIPS MEDICAL SYSTEMS M3150

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death