BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3150 UPGRADE REL N.0

    MDR report key: 6069326 · Received November 1, 2016

    Report

    Report Number
    1218950-2016-06836
    Event Type
    Death
    Date Received
    November 1, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 28, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER COMMUNICATIONS WITH THE RESPONSE CENTER ENGINEER (RCE), THE LOGS WERE COLLECTED LATE DUE TO CUSTOMER DELAY IN RESPONSE, THUS THE INFORMATION NEEDED WAS NO LONGER AVAILABLE FOR REVIEW. THE CUSTOMER ALLEGED THAT ON (B)(6) 2016 BETWEEN 12:00 - 14:00, AN ALARM FOR ROOM 3 DID NOT APPEAR ON MONITORS 9 AND 12 (CARE GROUPS). THE SYSTEM WAS NOT TESTED, BUT IS STILL IN USE. DUE TO THE DELAY IN OBTAINING INFORMATION FROM THE CUSTOMER, THE RCE STATED THAT THE CUSTOMER IS GOING TO MONITOR THE ISSUE, HOWEVER, THERE HAVE BEEN NO FURTHER OCCURRENCES OF THIS ISSUE SINCE THIS REPORT. THE CAUSE OF THE REPORTED ISSUE IS UNKNOWN, HOWEVER, IT WILL BE CONSIDERED A MALFUNCTION.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A BED-TO-BED OVERVIEW RED ALARM DID NOT OCCUR AT THE MONITOR AND APPEARS TO BE AN INTERMITTENT ISSUE. WAS NOTIFIED ON (B)(6) 2016 THAT THERE WAS A PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720997 M3150 UPGRADE REL N.0 CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 865423

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death