BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2091289 · Received April 20, 2011

    Report

    Report Number
    1218950-2011-01096
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Report Date
    March 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THEY COULD NOT SEE AN ECG WAVEFORM VIA PADS DURING A PATIENT EVENT. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND INVOLVED ACCESSORIES AND COULD NOT REPRODUCE THE REPORTED SYMPTOM. THE ELECTRONIC EVENT FILE WAS REVIEWED BY PHILIPS. THE DEVICE WAS BEHAVING AS DESIGNED. THIS WAS AN ISSUE RELATED TO USE OF THE LEAD SELECT BUTTON TO SELECT AN AVAILABLE WAVE FORM TO DISPLAY ON THE MRX DISPLAY, AND NOT A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY COULD NOT SEE AN ECG WAVEFORM VIA PADS DURING A PATIENT EVENT. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR