BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2083176 · Received April 13, 2011

    Report

    Report Number
    1218950-2011-01024
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    March 16, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A SHOCK EQUIPMENT MALFUNCTION. THERE WAS NO REPORTED PT INVOLVEMENT. PHILIPS EVALUATED THE PROBLEM AND CONFIRMED THE FAULT. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE PROBLEM. THE DEVICE PASSED ALL TESTS AND WAS PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SHOCK EQUIPMENT MALFUNCTION. THERE WAS NO REPORTED PT INVOLVEMENT. PHILIPS EVALUATED THE PROBLEM AND CONFIRMED THE FAULT. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE PROBLEM. THE DEVICE PASSED ALL TESTS AND WAS PUT BACK INTO SERVICE.

    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