BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8 V, 6.3 AH LI-ION BATTERY

    MDR report key: 2851410 · Received October 30, 2012

    Report

    Report Number
    1218950-2012-03631
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Report Date
    October 4, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    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 THE BATTERY IS NOT CHARGING. THERE WAS NO REPORTED PT INVOLVEMENT. THE PHILIPS FIELD SERVICE ENGINEER CONFIRMED THE BATTERY FAILURE WHERE THE BATTERY WAS NOT PROVIDING ANY POWER AND NOT CHARGING. THE DEVICE DID WORK ON AC POWER. THE BATTERY WAS 2 YEARS OLD. WE WILL CONSIDER THIS A MALFUNCTION OF THE BATTERY WHERE THE BATTERY WAS NOT PROVIDING ANY POWER AND NOT CHARGING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BATTERY IS NOT CHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BATTERY 14.8 V, 6.3 AH LI-ION BATTERY MKJ PHILIPS MEDICAL SYSTEMS M3538A 1021-157-P

    Patients

    Seq Age Sex Outcome Treatment
    1