BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART MRX

    MDR report key: 1853350 · Received October 1, 2010

    Report

    Report Number
    1218950-2010-01827
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER REPORTED A FAILURE TO DISCHARGE WHEN ATTEMPTING TO DELIVER ENERGY VIA EXTERNAL PADDLES OVER A CLEAR PLASTIC DRESSING ON THE PT'S CHEST. THE PT WAS IN THE OPERATING ROOM AFTER HAVING BYPASS SURGERY. THE PT'S CHEST WAS REOPENED AND THE PT WAS DEFIBRILLATED WITH INTERNAL PADDLES. THE INSTRUCTIONS FOR USE DIRECTS THE USER TO APPLY EXTERNAL PADDLES TO A BARE CHEST. THIS COMPLAINT REMAINS UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED A FAILURE TO DISCHARGE WHEN ATTEMPTING TO DELIVER ENERGY VIA EXTERNAL PADDLES OVER A CLEAR PLASTIC DRESSING ON THE PT'S CHEST. THE PT WAS IN THE OPERATING ROOM AFTER HAVING BYPASS SURGERY. THE PT'S CHEST WAS REOPENED AND THE PT WAS DEFIBRILLATED WITH INTERNAL PADDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention