BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2190121 · Received June 30, 2011

    Report

    Report Number
    1218950-2011-01854
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    June 1, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THEY SAW A PADS CABLE FAILURE MESSAGE IN TESTING. THERE WAS NO REPORT OF PT IMPACT OR INVOLVEMENT. THE CABLE WAS REPLACED BY THE CUSTOMER AND THEY WERE PROVIDED WITH INFO TO PERFORM THE OPCHECK CORRECTLY TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY SAW A PADS CABLE FAILURE MESSAGE IN TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE - ANDOVER M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1