BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHIUM ION BATTERY MODULE

    MDR report key: 4250447 · Received November 7, 2014

    Report

    Report Number
    1218950-2014-06748
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Report Date
    October 13, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHILIPS HEALTHCARE THAT THE BATTERY WAS NOT FUNCTIONING. THE DEVICE WOULD NOT POWER UP ON BATTERY POWER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718597 LITHIUM ION BATTERY MODULE MKJ MKJ PHILIPS MEDICAL SYSTEMS 989803167281 2013-09

    Patients

    Seq Age Sex Outcome Treatment
    1