BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2170835 · Received June 22, 2011

    Report

    Report Number
    1218950-2011-01777
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    May 24, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A LEADS ECG FAILURE WHILE PACING PATIENT. THE SAME FAILURE WAS OBSERVED WITH STIMULATOR. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEADS ECG FAILURE WHILE PACING PATIENT. THE SAME FAILURE WAS OBSERVED WITH STIMULATOR. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE - ANDOVER M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1