BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2080149 · Received April 6, 2011

    Report

    Report Number
    1218950-2011-00936
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    March 10, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    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 12-LEAD ECG ACQUISITION/SIGNAL LOSS ISSUES. THERE WAS NO REPORT OF NEGATIVE PT IMPACT. THE CUSTOMER HAD ALSO REPORTED LEADS ECG ARTIFACT AND THAT CHANGING THE LEADS ECG CABLES DID NOT RESOLVE THE ISSUE. THE UNIT WAS EVALUATED BY PHILIPS. THE SYMPTOM COULD NOT BE DUPLICATED AND THE DEVICE PASSED ALL TESTING, THEREFORE, WE CANNOT DETERMINE THE CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 12-LEAD ECG ACQUISITION/SIGNAL LOSS ISSUES. THERE WAS NO REPORT OF NEGATIVE 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