BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3810183 · Received February 4, 2014

    Report

    Report Number
    1218950-2014-00486
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Report Date
    January 9, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART MRX FAILED TO PACE AS THE PACER KEY DID NOT RESPOND DURING TREATMENT OF PT. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73761 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1