BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 6029501 · Received October 14, 2016

    Report

    Report Number
    1218950-2016-06502
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    September 17, 2016
    Report Date
    September 20, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A PHILIPS REPRESENTATIVE. THE DEVICE PASSED ALL REQUIRED TESTING AND WAS RETURNED TO THE CUSTOMER SITE. EVENT STRIPS AND/OR AN ELECTRONIC EVENT FILE WERE NOT AVAILABLE FOR REVIEW. PHILIPS IS UNABLE TO VERIFY THE REPORTED MALFUNCTION. PATIENT INFORMATION WAS REQUESTED, THE CUSTOMER DID NOT PROVIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THE DEVICE WAS UNABLE TO OBTAIN PACING CAPTURE DURING A PATIENT EVENT. THE INVOLVED PATIENT WAS STATED TO HAVE DESATURATED AFTER THE FIRST FAILED ATTEMPT. DURING THE SAME EVENT, THE CUSTOMER TRIED A SECOND TIME TO OBTAIN PACING AND WHEN UNABLE TO DO SO, THE PATIENT WENT ASYSTOLIC. A NON-PHILIPS DEVICE WAS THEN USED TO DELIVER PACING AND THE PATIENT STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681623 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other