BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 1696540 · Received May 17, 2010

    Report

    Report Number
    1218950-2010-00733
    Event Type
    Death
    Date Received
    May 17, 2010
    Date of Event
    April 15, 2010
    Report Date
    April 16, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CUSTOMER REPORTED A FAILURE TO DISCHARGE IN THE MANUAL MODE AND A BURNED HAIR SMELL AFTER DELIVERING SHOCKS. THE INVOLVED PT DIED APPROX 30 MINS LATER, BUT THE CUSTOMER DOES NOT ALLEGE THAT THE DEVICE WAS A FACTOR IN THE PT OUTCOME. THERE WAS NO EVENT SUMMARY OR ECG STRIPS AVAILABLE TO PHILIPS. ON 04/16/2010, THE DEVICE AND PADDLE SET WERE EVALUATED BY PHILIPS. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED AND THE EQUIPMENT PASSED ALL TESTING. WE ARE CONSIDERING THIS AS A MALFUNCTION BASED ON THE CUSTOMER REPORT ONLY. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOM AS IT COULD NOT BE REPLICATED. THE DEVICE HAS BEEN BACK IN USE SINCE 4/16/10, AND THERE HAVE BEEN NO PROBLEMS WITH THE DEVICE.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED A FAILURE TO DISCHARGE IN THE MANUAL MODE AND A BURNED HAIR SMELL AFTER DELIVERY SHOCKS. THE CUSTOMER DOES NOT ALLEGE THAT THE DEVICE WAS A FACTOR IN THE PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death