BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL

    MDR report key: 489156 · Received October 15, 2003

    Report

    Report Number
    489156
    Event Type
    Malfunction
    Date Received
    October 15, 2003
    Date of Event
    November 1, 2002
    Report Date
    November 1, 2002
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEART RATE (HR) DISPLAYED ON BEDSIDE MONITOR (PHILIPS V24) WAS 85 BPM. ACTUAL HR WAS 120-125 BPM. CENTRAL MONITOR DISPLAYED THE CORRECT HR. PROBLEM DISAPPEARED AFTER CENTRAL MONITOR WAS RE-BOOTED. RE-BOOTING IS NOT A ROUTINE PROCEDURE. THE DISCREPANCY HAD CONTINUED FOR SEVERAL HOURS WITH THIS PT WITHOUT ADVERSE EFFECT. THERE WAS NO INTERFERENCE NOTED IN THIS INCIDENT. THERE WAS NO MFR INSTRUCTIONS NOR LABEL WARNINGS ABOUT POSSIBLE DEVICE INTERACTIONS. THERE WERE NO UNUSUAL CIRCUMSTANCES NOR OCCURRENCES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE FACILITY IS NOT AWARE OF THIS OCCURRENCE WITH OTHER PT. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL CENTRAL PATIENT MONITOR DRT PHILIPS MEDICAL SYSTEMS, INC. M3150A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Other