BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2083157 · Received April 13, 2011

    Report

    Report Number
    1218950-2011-01009
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    March 14, 2011
    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 CUSTOMER REPORTED THAT THE AC / DC POWER INDICATOR LED GOES OUT AFTER DELIVERING A SHOCK AND THE UNIT WOULD THEN FAIL TO POWER UP ON AC POWER. THERE WAS NO REPORT OF PT INVOLVEMENT. THE CUSTOMER ORDERED A NEW AC POWER MODULE WHICH RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC / DC POWER INDICATOR LED GOES OUT AFTER DELIVERING A SHOCK AND THE UNIT WOULD THEN FAIL TO POWER UP ON AC POWER. 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