BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART START XL

    MDR report key: 1832003 · Received September 8, 2010

    Report

    Report Number
    1218950-2010-01513
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 2, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT DURING A SYNCHRONIZED CARDIOVERSION, THE PT HAD AN EPISODE OF VENTRICULAR FIBRILLATION. AT THIS TIME, THERE HAS BEEN NO DETERMINATION AS TO WHETHER THE DEVICE WAS A FACTOR IN THE REPORTED OUTCOME OF THE PT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A SYNCHRONIZED CARDIOVERSION, THE PT HAD AN EPISODE OF VENTRICULAR FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention