BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART START XL

    MDR report key: 3763301 · Received April 7, 2014

    Report

    Report Number
    1218950-2014-01934
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 20, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO DELIVER TRANSCUTANEOUS PACING WITH THIS DEVICE DURING A PT EVENT. THE PT THEN REQUIRED DEFIBRILLATION. THE PT WAS SHOCKED, THE RHYTHM CONVERTED AND THE PT WAS REPORTED TO BE IN CRITICAL CONDITION. THE IMPACT OF THE DEVICE BEHAVIOR HAS NOT YET BEEN REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205562 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention