BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2891090 · Received November 14, 2012

    Report

    Report Number
    1218950-2012-03771
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 19, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A FAILURE TO ACQUIRE ECG LEAD 6 DURING A 12 LEAD ECG. THERE WAS NO NEGATIVE PT IMPACT. THE DEVICE WAS SENT TO THE PHILIPS BENCH FOR EVAL. THE ISSUE WAS REPRODUCED AND THE ISSUE WAS ISOLATED TO THE ECG LEADS AND TRUNK CABLES. THE ECG LEADS AND TRUNK CABLES WERE REPLACED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER. WE CANNOT DETERMINE THE CAUSE OF THE MALFUNCTION AS MULTIPLE PARTS WERE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO ACQUIRE ECG LEAD 6 DURING A 12 LEAD ECG. THERE WAS NO NEGATIVE PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1