BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M3151 INFORMATION CENTER CLIENT REL N.0

    MDR report key: 3203697 · Received June 24, 2013

    Report

    Report Number
    1218950-2013-01841
    Event Type
    Injury
    Date Received
    June 24, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A TELEMETRY PT WAS BEING MONITORED AND THERE WAS A 25 SECOND SIGNAL LOSS. AFTER THE SIGNAL LOSS THE NURSES FOUND THE PT HAVING A LETHAL ARRHYTHMIA THAT REQUIRED IMMEDIATE MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285888 M3151 INFORMATION CENTER CLIENT REL N.0 MHX PHILIPS MEDICAL SYSTEMS M3151

    Patients

    Seq Age Sex Outcome Treatment
    1 Death