BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 2844789 · Received November 1, 2012

    Report

    Report Number
    1218950-2012-03672
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Report Date
    October 26, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE BATTERY WAS NOT DETECTED. NO PT INVOLVEMENT WAS REPORTED. THE CUSTOMER EVALUATED THE DEVICE. THE CUSTOMER LOCALIZED THE ISSUE TO A FAILED BATTERY. NOTE THAT THE IDENTIFIED FAILED BATTERY WAS APPROX 3 YEARS OLD. WE ARE CONSIDERING THIS A MALFUNCTION OF THE BATTERY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BATTERY WAS NOT DETECTED. NO PT INVOLVEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1