BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 4161641 · Received July 23, 2014

    Report

    Report Number
    1218950-2014-04260
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 30, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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

    IT WAS REPORT INITIALLY REPORTED A FAILURE OF THE HEART START XI CONNECTOR TO POWER THE DEVICE. IT WAS LATER CLARIFIED THAT WHEN THE HEART START XL IS UNPLUGGED THE SOCKET COMES OUT OF THE DEFIBRILLATOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND/OR PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430106 HEART START XL MKJ MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1