BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART FRX

    MDR report key: 4921746 · Received July 17, 2015

    Report

    Report Number
    3030677-2015-01699
    Event Type
    Death
    Date Received
    July 17, 2015
    Report Date
    July 14, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    050004
    Removal / Correction Number
    Z-0642-2013, Z-0643-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILS BATTERY INSERTION TEST. THERE WAS NO NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464815 HEARTSTART FRX AED MKJ PHILIPS MEDICAL SYSTEMS 861304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death