BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-LON BATTERY

    MDR report key: 4230162 · Received October 24, 2014

    Report

    Report Number
    1218950-2014-06446
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    October 6, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM SHUTS OFF DURING USE AND GAVE A RED X. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677936 BATTERY 14.8V, 6.3 AH LI-LON BATTERY MKJ PHILIPS MEDICAL SYSTEMS M3538A 0720-026-P

    Patients

    Seq Age Sex Outcome Treatment
    1