BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-LON BATTERY

    MDR report key: 2212723 · Received July 12, 2011

    Report

    Report Number
    1218950-2011-01975
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Report Date
    June 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO CHARGE. THERE WAS NO REPORT OF PT INVOLVEMENT. ON (B)(6) 2011 IT WAS FURTHER CLARIFIED THAT THE UNIT FAILED TO POWER UP ON BATTERY POWER. THE CUSTOMER WAS PROVIDED WITH THE INFORMATION TO ORDER A NEW ONE. WE WILL CONSIDER THIS A FAILURE OF THE BATTERY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO 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-LON BATTERY MKJ PHILIPS HEALTHCARE - ANDOVER M3538A 0945-383-P

    Patients

    Seq Age Sex Outcome Treatment
    1