BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX

    MDR report key: 3834424 · Received May 19, 2014

    Report

    Report Number
    1218950-2014-02838
    Event Type
    Death
    Date Received
    May 19, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 8, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS HEALTHCARE TO REPORT THAT WHILE DELIVERING TRANSCUTANEOUS PACING TO A PATIENT, THERE WAS AN ERROR MESSAGE THAT INTERRUPTED PACING. THE INVOLVED PATIENT DIED. IT HAS NOT YET BEEN REPORTED WHETHER THE DEVICE BEHAVIOR IMPACTED THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295375 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death