BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 6107341 · Received November 16, 2016

    Report

    Report Number
    9610816-2016-00298
    Event Type
    Death
    Date Received
    November 16, 2016
    Date of Event
    October 24, 2016
    Report Date
    November 7, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    NO MALFUNCTION COULD BE IDENTIFIED. PHILIPS CANNOT RULE OUT A MALFUNCTION OF THE DEVICE, AS THE ALARM DATA FOR REVIEW WAS NO LONGER PRESENT, DUE TO THE PASSAGE OF TIME. BECAUSE OF THIS, IT IS NOT ABLE TO BE DETERMINED IF THERE WERE ACTIVE ALARMS AT THE REPORTED TIME OF THE EVENT. A PHILIPS PRODUCT SERVICE ENGINEER (PSE) REVIEWED THE INFORMATION THAT WAS AVAILABLE, AND NO IRREGULARITIES NOR DATA STREAM INTERRUPTIONS FOR THE PATIENT MONITOR AT "BETT22" WERE DOCUMENTED IN THE LOG. THE PSE FOUND THAT FROM THE (B)(6) 2016 AT 04:39:40, A 5 MINUTE DATA GAP WAS RECORDED. DURING THIS PERIOD, NO DATA WAS PROVIDED TO THE CONTROL CENTER BY THE PATIENT MONITOR AT BETT22; EITHER THE PATIENT MONITOR LOST THE CONNECTION TO THE NETWORK BY AN INTERRUPTION (POSSIBLY GENERATED MANUALLY) OR THE DEVICE WAS NOT IN OPERATION DURING THIS TIME (POSSIBLY SWITCHED OFF). FROM 04:44:16 CLOCK TO 04:48:17 CLOCK, A 4 MINUTE CONNECTION EXISTED FROM THE PATIENT MONITOR TO THE CONTROL CENTER. AT 04:48:17, THE ENTRY IN THE LOG SHOWS THAT THE BEDSIDE MONITOR AGAIN DID NOT TRANSMIT DATA TO THE CONTROL CENTER. NO FURTHER INFORMATION IS AVAILABLE. THERE HAVE BEEN NO SUBSEQUENT CALLS LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT DIED AND WANTED TO KNOW IF AND WHEN THE ALARMS WERE SWITCHED OFF. THEY NEED ASSISTANCE WITH OBTAINING LOG FILES. THE INCIDENT IN THE HOSPITAL OCCURRED ON (B)(6), BETWEEN 12:00AM TO 4:00AM ON A BED LABELED BETT22.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT DIED AND WANTED TO KNOW IF AND WHEN THE ALARMS WERE SWITCHED OFF. THEY NEED ASSISTANCE WITH OBTAINING LOG FILES. THE PATIENT DIED. THE INCIDENT IN THE HOSPITAL OCCURRED ON (B)(6) 2016, BETWEEN 12:00AM TO 4:00AM ON A BED LABELED ¿BETT22¿. PHILIPS IS NOT ABLE TO DETERMINE IF THE USE OF THIS MONITOR WAS CAUSAL OR CONTRIBUTORY TO THE PATIENT DEATH. AFTER THE PATIENT DIED, A MINIMUM OF ONE FURTHER PATIENT WAS MONITORED WITH THE SAME MONITOR AND CENTRAL STATION. AFTER THE PATIENT DIED, A MINIMUM OF ONE FURTHER PATIENT WAS MONITORED WITH THE SAME MONITOR AND CENTRAL STATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755777 MP30 INTELLIVUE PATIENT MONITOR COMPACT PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8002A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death