BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 4231734 · Received October 14, 2014

    Report

    Report Number
    1218950-2014-06110
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 20, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY WAS NOT CHARGING. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648760 HEARTSTART SLA BATTERY DQA, MKJ, LDD, DRO DQA PHILIPS MEDICAL SYSTEMS M3516A LK-2013-08

    Patients

    Seq Age Sex Outcome Treatment
    1