BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSRAT XL

    MDR report key: 3897023 · Received May 16, 2014

    Report

    Report Number
    1218950-2014-02764
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Report Date
    April 25, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MJK
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS HEALTHCARE TO REPORT THAT THE "EQUIPMENT IS NOT SYNCHRONIZING WITH THE PACEMAKER". THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294661 HEARTSRAT XL MJK PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1