BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3150 INFORMATION CENTER LOCAL DATABASE

    MDR report key: 2212859 · Received August 5, 2011

    Report

    Report Number
    1218950-2011-02267
    Event Type
    Death
    Date Received
    August 5, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 27, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MHX
    PMA / PMN Number
    K050742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT A PT WITH ARRHYTHMIA WAS BEING MONITORED BUT THE AUDIBLE AND VISUAL ALARMS DID NOT ALARM AT THE IIC. THE ALARMS APPEARED ON THE BEDSIDE MONITOR, BUT AUDIBLE ALARMING HAD BEEN DISABLED AT THE BEDSIDE. THE CLINICAL STAFF WAS FULLY AWARE OF THE PT'S CONDITION. THE PT EVENTUALLY EXPIRED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT WITH ARRHYTHMIA WAS BEING MONITORED BUT THE AUDIBLE AND VISUAL ALARMS DID NOT ALARM AT THE IIC. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M3150 INFORMATION CENTER LOCAL DATABASE MHX PHILIPS HEALTHCARE - ANDOVER 862173 (M3150)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death