BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2031785 · Received March 21, 2011

    Report

    Report Number
    1218950-2011-00763
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    February 24, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE UNIT WOULD NOT ACQUIRE THE 12 LEAD ECG, THE UNIT WAS EVALUATED AT PHILIPS. THE SYMPTOM COULD NOT BE DUPLICATED AND THE DEVICE PASSED ALL TESTING. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE SINCE WE COULD NOT DUPLICATE THE SYMPTOM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WOULD NOT ACQUIRE THE 12 LEAD ECG, THE UNIT WAS EVALUATED AT PHILIPS.

    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