BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERU

    MDR report key: 2920317 · Received December 17, 2012

    Report

    Report Number
    1218950-2012-04112
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Report Date
    December 3, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2012, THE CUSTOMER REPORTED THAT THE LITHIUM BATTERY FOR MRX'S WAS NOT HOLDING A CHARGE. THERE WAS NO REPORT OF PT INVOLVEMENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE CUSTOMER REPORTED THAT THE LITHIUM BATTERY FOR MRX'S WAS NOT HOLDING A CHARGE. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BATTERY 14.8V, 6.3 AH LI-ION BATTERU MKJ PHILIPS MEDICAL SYSTEMS M3538A 1111

    Patients

    Seq Age Sex Outcome Treatment
    1