BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 3952243 · Received May 13, 2014

    Report

    Report Number
    1218950-2014-02725
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Report Date
    April 22, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER TESTING OF THE DEVICE, REPLACEMENT OF THE BATTERY WAS REQUIRED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285606 HEARTSTART SLA BATTERY DQA, MKJ, LDD, DRO DQA PHILIPS MEDICAL SYSTEMS M3516A 03/19/2005

    Patients

    Seq Age Sex Outcome Treatment
    1