BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2041389 · Received March 9, 2011

    Report

    Report Number
    1218950-2011-00665
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Report Date
    February 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE BATTERY CHARGE LED WAS AMBER. THERE WAS NO REPORT OF PT INVOLVEMENT. A PHILIPS FIELD SVC ENGINEER WENT TO THE CUSTOMER SITE AND VERIFIED THE FAILURE. THE UNIT FAILED TO POWER UP ON BATTERY POWER. REPLACEMENT OF THE BATTERY RESOLVED THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY CHARGE LED WAS AMBER. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA MKJ PHILIPS HEALTHCARE M3516A

    Patients

    Seq Age Sex Outcome Treatment
    1