BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHIUM ION BATTERY MODULE

    MDR report key: 4250453 · Received November 7, 2014

    Report

    Report Number
    1218950-2014-06761
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Report Date
    October 15, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT "EVEN THOUGH THE BATTERY IS FULLY CHARGED, A LOW BATTERY MESSAGE IS DISPLAYED". THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718643 LITHIUM ION BATTERY MODULE MKJ MKJ PHILIPS MEDICAL SYSTEMS 989803167281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown