BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 2231438 · Received August 25, 2011

    Report

    Report Number
    1218950-2011-02518
    Event Type
    Death
    Date Received
    August 25, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 28, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVIC UNEXPECTEDLY SHUTDOWN DURING USE ON A PT. THERE WAS NO REPORT THAT DEVICE BEHAVIOR IMPACTED PT OUTCOME. THE DEVICE WAS NOT EVALUATED BY PHILIPS. THE CUSTOMER'S BIOMEDICAL DEPT EVALUATED THE DEVICE AND LOCALIZE THE ISSUE TO A FAILED BATTERY. THE CUSTOMER REPLACED THE BATTERY AND WAS PROVIDED WITH INFO RELATED TO BATTERY MAINTENANCE. WE WILL CONSIDER THIS A BATTERY MALFUNCTION BASED ON THE CUSTOMER REPORT ONLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE UNEXPECTEDLY SHUTDOWN DURING USE ON A PT. THERE WAS NO REPORT THAT DEVICE BEHAVIOR IMPACTED PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1