BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 2111646 · Received May 26, 2011

    Report

    Report Number
    1218950-2011-01513
    Event Type
    Death
    Date Received
    May 26, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A FAILURE TO DISCHARGE DURING A PATIENT EVENT. THE INVOLVED PATIENT DIED BUT THE CUSTOMER HAS REPORTED THAT THE DEVICE WAS NOT A FACTOR IN THE PATIENT OUTCOME. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO DISCHARGE DURING A PATIENT EVENT. THE INVOLVED PATIENT DIED BUT THE CUSTOMER HAS REPORTED THAT THE DEVICE WAS NOT A FACTOR IN THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1