BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2220514 · Received July 18, 2011

    Report

    Report Number
    1218950-2011-02043
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Report Date
    June 20, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED UNABLE TO ACQUIRE V4 ON A 12 LEAD ECG. THERE WAS NO REPORTED ADVERSE PT IMPACT. THE CUSTOMER ORDERED A REPLACEMENT TO RESOLVE THE ISSUE. THE MRX CABLE WAS NOT AVAILABLE FOR EVAL. WE WILL CONSIDER THIS A MALFUNCTION OF THE MRX CABLE WHICH CAUSED THE V4 FAILURE ON A 12 LEAD ECG.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNABLE TO ACQUIRE V4 ON A 12 LEAD ECG. THERE WAS NO REPORTED ADVERSE PT 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