BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2102351 · Received May 18, 2011

    Report

    Report Number
    1218950-2011-01416
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Report Date
    April 22, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT DURING A 12 LEAD ECG, THE DEVICE DISPLAYED ALL THE LEADS WERE OFF. THERE WAS NO REPORTED ADVERSE PT IMPACT. THE PHILIPS CALL CENTER CALLED THE CUSTOMER BACK AND WAS TOLD THAT THE PROBLEM WAS RESOLVED. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE FROM THE AVAILABLE INFO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A 12 LEAD ECG, THE DEVICE DISPLAYED ALL THE LEADS WERE OFF. 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 M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1