BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1934551 · Received December 3, 2010

    Report

    Report Number
    1218950-2010-02476
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Report Date
    November 8, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE BIOMEDICAL ENGINEER REPORTED THAT THE DEVICE WOLD NOT POWER ON AS EXPECTED. THERE WAS NO REPORT OF PT INVOLVEMENT. THE BIOMED ISOLATED THE PROBLEM TO THE POWER SUPPLY. REPLACEMENT OF THE POWER SUPPLY RESOLVED THE PROBLEM.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE DEVICE WOULD NOT POWER ON AS EXPECTED. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC POWER MODULE MKJ PHILIPS HEALTHCARE M3539A

    Patients

    Seq Age Sex Outcome Treatment
    1