BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 2082014 · Received April 26, 2011

    Report

    Report Number
    1218950-2011-01132
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Report Date
    March 29, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE UNIT FAILED TO RECOGNIZE THE BATTERY. THERE WAS NO REPORT OF PT INVOLVEMENT. PHILIPS DUPLICATED THE REPORTED SYMPTOM. THE CUSTOMER WAS SENT A NEW BATTERY WHICH RESOLVED THE FAILURE. WE WILL CONSIDER THIS A FAILURE OF THE BATTERY.

    Description of Event or Problem · 1

    THE UNIT FAILED TO RECOGNIZE THIS BATTERY. 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 BATTERY MKJ PHILIPS HEALTHCARE M3538A 1029-317-P

    Patients

    Seq Age Sex Outcome Treatment
    1