BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3751519 · Received December 17, 2013

    Report

    Report Number
    1218950-2013-06499
    Event Type
    Malfunction
    Date Received
    December 17, 2013
    Report Date
    November 18, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GI
    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 XL DISPLAYED ERROR CODES 90007 AND 900808 FAILING PACER TEST WHICH WERE NOT CLEARED BY OPCHECK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658224 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A NA

    Patients

    Seq Age Sex Outcome Treatment
    1