BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 2112414 · Received May 24, 2011

    Report

    Report Number
    1218950-2011-01460
    Event Type
    Death
    Date Received
    May 24, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DID NOT DELIVER 4 OR 5 SHOCKS TO A PT. THE INVOLVED PT DIED BUT THE CUSTOMER STATED THAT DEVICE BEHAVIOR DID NOT IMPACT PT OUTCOME. THE DEVICE WAS NOT EVALUATED BY PHILIPS. THE BIOMED AT THE CUSTOMER EVALUATED THE DEVICE AND COULD NOT REPRODUCE THE REPORTED SYMPTOM. IT WAS DETERMINED THAT THE DEVICE HAD DISPLAYED A 'NO SHOCK DELIVERED' MESSAGE AT THE TIME OF THE EVENT. THE 'NO SHOCK DELIVERED' MESSAGE IS GENERATED IN SITUATIONS WHERE THERE IS OUT OF RANGE HIGH IMPEDANCE. THE DEVICE WAS FUNCTIONING AS DESIGNED AND THERE WAS NO MALFUNCTION. THIS WAS A USE ISSUE RELATED TO CUSTOMER UNDERSTANDING OF SITUATIONS CAUSING OUT OF RANGE HIGH IMPEDANCE THAT GENERATE THIS ON-SCREEN MESSAGE. INFORMATION WAS PROVIDED TO THE CUSTOMER TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT DELIVER 4 OR 5 SHOCKS TO A PT .

    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