BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-LON BATTERY

    MDR report key: 2051372 · Received April 4, 2011

    Report

    Report Number
    1218950-2011-00899
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT WOULD INTERMITTENTLY SHOW A RED X AND IN TESTING THE BATTERY, IT WOULD SOMETIMES FAIL TO POWER UP. ON (B)(6) 2011, A PHILIPS INVESTIGATOR SPOKE WITH THE CUSTOMER WHO REPORTED THAT THE BATTERY WAS A REV C BATTERY WHICH IS MORE THAN 5 YEARS OLD. THE CUSTOMER REPLACED THE BATTERY WHICH RESOLVED THE FAILURE. THE CUSTOMER WAS INFORMED THAT THE BATTERIES SHOULD BE REPLACED EVERY 2 YEARS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WOULD INTERMITTENTLY SHOW A RED X AND IN TESTING THE BATTERY, IT WOULD SOMETIMES FAIL TO POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BATTERY 14.8V, 6.3 AH LI-LON BATTERY MKJ PHILIPS HEALTHCARE M3538A

    Patients

    Seq Age Sex Outcome Treatment
    1