BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL SYSTEM

    MDR report key: 432210 · Received December 12, 2002

    Report

    Report Number
    432210
    Event Type
    Malfunction
    Date Received
    December 12, 2002
    Date of Event
    November 12, 2002
    Report Date
    November 19, 2002
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEARTSTREAM XL #80 WAS CONNECTED TO PT. MONITOR WAS PLUGGED IN. PACER MODE - DEMAND, RATE 60, MA120. PT WAS BEING PACED INTERMITTENTLY - RHYTHM VARIED FROM PACED TO JUNCTIONAL (ACCELERATED). MONITOR SUDDENLY WAS WITHOUT POWER. REMAINED PLUGGED IN & BATTERY WAS IN PLACE. PT HAD ACCELERATED JUNCTIONAL RHYTHM - VITAL SIGNS WERE UNCHANGED. IMMEDIATELY CONNECTED PT TO HEART STREAM XL #32, PREVIOUS PACE SETTINGS RESUMED. BIOMED NOTIFIED STAT. BATTERY EXCHANGED WITH FULLY CHARGED BATTERY - NO POWER. MONITOR PLUGGED TO DIFFERENT OUTLET - NO POWER. DIFFERENT PLUG ALSO USED - NO POWER. MONITOR TAKEN ON/OFF - NO POWER. MONITOR TO BIOMED. VERIFIED NO POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEM HEARTSTREAM DEFIB. SYSTEM MKJ PHILIPS MEDICAL SYSTEMS M 4735A *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other