BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 1012521 · Received March 11, 2008

    Report

    Report Number
    1218950-2008-00136
    Event Type
    Death
    Date Received
    March 11, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL DID NOT PROVIDE THE PT INFORMATION. THE CUSTOMER STATED THAT THEY HAD RECENTLY UPGRADED THEIR INFORMATION CENTER TO RELEASE K AND SUBSEQUENTLY THEY HAD A PATIENT DEATH OCCUR INVOLVING A ECG LEADS OFF EVENT THAT THEY WERE NOT CERTAIN ALARMS WERE PROVIDED FOR. POST-INCIDENT A PHILIPS FIELD SERVICE ENGINEER (FSE), WENT ONSITE AND COMPLETED PERFORMANCE TESTING ON THE INVOLVED DEVICE WHICH PASSED PERFORMANCE TESTING. STRIPS WERE COLLECTED WHICH SHOWED THAT THE ECG LEADS CAME OFF AT 3:25 AND WERE NOT BACK ON THE PATIENT UNTIL 4:15. LOGS SHOW THAT DURING THE LEADS OFF TIMEFRAME, THE PATIENT DID HAVE A DESAT 78 < 80 ALARM OCCUR. THERE IS NO INDICATION OF THAT ALARM BEING SILENCED AT THE CENTRAL, HOWEVER, NO FURTHER STATEMENTS CAN BE MADE REGARDING IF THIS ALARM WAS SILENCED IN THE ROOM OR IF IT CONTINUED TO RING AS LOGS DO NOT TRACK WHEN ALARMS STOP RINGING WHEN THEY ARE SILENCED AT THE CENTRAL (VS BEDSIDE) IS THERE AN ENTRY IN THE LOG. THE RECENT SOFTWARE UPGRADE WAS RELATED TO THIS EVENT. THIS CUSTOMER RECEIVED A COPY OF THE LEADS OFF INOP LETTER ON NOV. 14, 2005. A COPY OF THIS LETTER HAS BEEN ATTACHED. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED THE REMOTE TECHNICAL ASSISTANCE CENTER (R-TAC) ASKING FOR HELP IN OBTAINING INFORMATION FROM THE LOGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS INFORMATION CENTER CENTRAL STATION MONITOR DRT PHILIPS MEDICAL SYSTEMS M3150B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death