BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 1012632 · Received March 11, 2008

    Report

    Report Number
    1218950-2008-00149
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 21, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POST-INCIDENT, THE INVOLVED DEVICE WAS TESTED AND THE DEVICE TESTED TO SPECIFICATIONS, INCLUDING AUDIBLE ALARMS. LOGS WERE COLLECTED AND ANALYZED BY A PHILIPS PRODUCT SUPPORT ENGINEER (PSE). THE LOGS INDICATE THAT 9 RED ALARM EVENTS WERE PROVIDED BETWEEN 4:54 AM AND 5:22 AM WITH BOTH SILENCE AND SUSPEND USER ACTIONS TAKEN, SUPPORTING THAT STAFF WERE AWARE OF ALARM OCCURRENCES AND WERE INTERACTING WITH THE DEVICE AT THE TIME OF THE ALARMS. THE HOSPITAL CONTACT ALSO STATED THAT THE HOSPITAL IS TAKING INTERNAL ACTION IN REGARDS TO THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY DID NOT HEAR AN AUDIBLE ALARM WHEN A PT WAS IN V-TACH.

    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