BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1221083 · Received October 10, 2008

    Report

    Report Number
    1221083
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    April 23, 2008
    Report Date
    October 10, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    CARDIAC TELEMETRY BOX WAS SOUNDING OFF ALARM WITH WRONG READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MONITOR, TELEMETRY, TRANSMITTER MHX PHILIPS MEDICAL SYSTEMS M2601B *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR