BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3983467 · Received June 27, 2014

    Report

    Report Number
    1218950-2014-03718
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    May 30, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A CARD REPLACEMENT WAS REPORTED TO PHILIPS HEALTHCARE FOR THE HEARTSTART XL, ADDITIONALLY IT WAS ALSO NOTED "ERROR HAPPENS AFTER THE PREVENTIVE MAINTENANCE". THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377036 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1