BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 4250075 · Received August 21, 2013

    Report

    Report Number
    1218950-2014-05065
    Event Type
    Malfunction
    Date Received
    August 21, 2013
    Report Date
    August 4, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BATTERY CALIBRATION FAILURE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407235 BATTERY 14.8V, 6.3 AH LI-ION BATTERY MKJ PHILIPS MEDICAL SYSTEMS M3538A

    Patients

    Seq Age Sex Outcome Treatment
    1