BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 3043415 · Received March 12, 2013

    Report

    Report Number
    1218950-2013-00871
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 14, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED AN INTERMITTENT ECG WAVEFORM BUT DID NOT SPECIFY IF IT WAS LEAD OR PADS. THERE WAS NO NEGATIVE PT IMPACT. PHILIPS MADE ATTEMPTS WITH THE CUSTOMER TO EVALUATE THE DEVICE. THE CUSTOMER DECLINED SERVICING OF THE DEVICE AT THIS TIME. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOM AS THE CUSTOMER DECLINED SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT ECG WAVEFORM BUT DID NOT SPECIFY IF IT WAS LEAD OR PADS. THERE WAS NO NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104248 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1