BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA

    MDR report key: 1133004 · Received August 20, 2008

    Report

    Report Number
    1218950-2008-00454
    Event Type
    Death
    Date Received
    August 20, 2008
    Date of Event
    July 26, 2008
    Report Date
    July 28, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION, AND NO REQUEST FOR DEVICE TESTING. THE CUSTOMER DID PROVIDE THE LOGS FOR REVIEW BY PHILIPS CLINICAL SPECIALIST WHO DETERMINED THAT THE LOGS DID SHOW THAT SOME CRITICAL EVENTS HAD OCCURRED (I.E. RED ALARMS, SILENCING/SUSPENDING). EVENTS SUCH AS YELLOW ALARMS AND INOPERATIVES MAY ALSO HAVE BEEN OCCURRING BUR ARE NOT LOGGED AT THE CENTRAL STATION. THE LOGS DO SHOW THAT THE ALARMS WERE SUSPENDED ON JULY 26 AT 1: 56 AM AND 2:05AM. THE ALARMS WERE NOT SUSPENDED AT 1:59 AM AND 2:08PM AND WERE NOT SUSPENDED AT LATER TIMES, INCLUDING AROUND 3:00AM WHEN THE PT EXPIRED. BASED ON THE INFO PROVIDED BY THE CUSTOMER, THE ABSENCE OF DATA FOLLOWED BY A SERIES OF RED ALARMS STARTING AT 3:51 AM IS FULLY CONSISTENT WITH THE LEADS BEING OFF AND THEN RE-APPLIED AT THE TIME THE RED ALARMS ARE NOTED. THERE IS NO EVIDENCE TO SUPPORT THAT A DEVICE MALFUNCTION OCCURRED. THE CUSTOMER DID PERFORM THEIR OWN TESTING WITH BIOMED AND FOUND THAT THE DEVICE RESPONDED AND ALARMED DURING THE INCIDENT AS INTENDED. A PHILIPS ENGINEER WAS ALSO ON SITE TO PERFORM TESTS AND RECEIVED BOTH VISUAL AND AUDIBLE ALARMS. THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PT INCIDENT,THE ALARMS DID NOT SOUND AT THE CENTRAL STATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA MHX PHILIPS MEDICAL SYSTEMS M3155B

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death