BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 3060676 · Received March 26, 2013

    Report

    Report Number
    1218950-2013-01048
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 4, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    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 DURING A 12 LEAD ECG THE V5 LEAD WAS INTERMITTENT. THERE IS NO REPORTED PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE REPORTED SYMPTOM WAS CONFIRMED. THE ISSUE WAS ISOLATED TO THE ECG TRUNK CABLE. THE ECG TRUNK CABLE WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE THEN PASSED ALL REQUIRED TESTING AND REMAINS AT THE CUSTOMER SITE FOR USE. THIS WAS A MALFUNCTION OF THE ECG TRUNK CABLE. REPLACEMENT OF THE TRUNK CABLE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A 12 LEAD ECG THE V5 LEAD WAS INTERMITTENT. THERE IS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124619 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1