BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2142664 · Received June 21, 2011

    Report

    Report Number
    1218950-2011-01735
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    May 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED UNABLE TO ACQUIRE 12 LEADS ECG. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. PHILIPS EVALUATED THE DEVICE AND NO TROUBLE WAS FOUND. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTING AND WAS RETURNED TO USE. PHILIPS IS NOT ABLE TO CONFIRM THE REPORTED PROBLEM. BECAUSE THE PROBLEM COULD NOT BE RECREATED THE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNABLE TO ACQUIRE 12 LEADS ECG. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    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