BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3043433 · Received March 12, 2013

    Report

    Report Number
    1218950-2013-00866
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A FAILURE TO DISCHARGE. THERE WAS NO PT INVOLVEMENT. THIS WAS FOUND DURING TESTING. THE DEVICE WAS RETURNED TO PHILIPS FOR EVAL. THE REPORTED SYMPTOM WAS CONFIRMED. THE SHOCK BUTTON AND INSERT WERE REPLACED TO RESOLVE THE PROBLEM. AFTER PASSING ALL TESTING THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE SHOCK BUTTON/FAILURE TO DISCHARGE ISSUE WAS RESOLVED WITH REPLACEMENT OF THE SHOCK BUTTON AND INSERT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO DISCHARGE. THERE WAS NO PT INVOLVEMENT. THIS WAS FOUND DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104377 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1