BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS AVENT DOUBLE ELECTRIC BREAST PUKP

    MDR report key: 5141496 · Received October 2, 2015

    Report

    Report Number
    8021997-2015-00012
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    March 13, 2015
    Report Date
    November 12, 2015
    Manufacturer
    PHILIPS ELECTRONICS UK LIMITED
    Product Code
    HGX
    PMA / PMN Number
    K052047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION, (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    DFU CLEARLY INSTRUCTS CUSTOMER TO CHECK CABLES BEFORE EVERY SINGLE USE. THIS ADVERSE IS GIVEN IN ORDER TO PREVENT INCIDENTS THAT CABLE IS DAMAGED (E. G. BY BENDING) AND THAT CUSTOMER IS EXPOSED TO UNSAFE SITUATION BY USING EACH CABLE PICTURES US ATTACHED EVAL SHOW THAT CABLE WAS HANDED AND THAT CAN CAUSE FRACTURE OF THE INSULATION. CUSTOMER STATED THAT THEY WERE AWARE THAT CABLE WAS DAMAGED AND WILL CHOOSE TO USE IT ("CORD WAS STARTING WEAR AND PLASTIC WAS THIN AND HAD EXPOSED WIRES.") IN THIS CASE, CUSTOMER DIDN'T FOLLOW INSTRUCTIONS STATED IN THE DFU.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION, 09/04/2015 AND 09/16/2015. THE DEVICE HAS NOT BEEN RETURNED. THIS IS THE FIRST TIME THAT SUCH INCIDENT IS REPORTED. WITHOUT RECEIVING PLUG AND COMPLETE PRODUCT FOR TECHNICAL INVESTIGATION AND BASED ONLY ON THE DESCRIPTION OF THE CUSTOMER IS NOT POSSIBLE TO CLARIFY THE ROOT CAUSE OF THE INCIDENT. TAKING INTO ACCOUNT THAT NO SPARKING, EXCESSIVE TEMPERATURE OR OTHER HAZARDOUS SITUATIONS (E.G. PLUG IS DAMAGED IN SUCH WAY THAT HV VOLTAGE COMPONENTS BECOME ACCESSIBLE) ARE REPORTED WE CAN CONCLUDE THAT NO SAFETY RISK OCCURRED. WE WILL MONITOR POSSIBLE NEW CASES AND TAKE AN ACTION IF NEEDED.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE CUSTOMER TRIED TO REMOVE THE PLUG FROM THE WALL SOCKET AND PART OF THE PLUG STAYED IN THE SOCKET. AN ELECTRICIAN WAS CALLED TO THE HOME TO REMOVE THE PLUG FROM THE SOCKET.

    Description of Event or Problem · 1

    (B)(6) 2015, CUSTOMER CLAIMS WHEN SHE PLUGGED THE PUMP (DOUBLE ELECTRIC BREAST PUMP) IN IT POPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657348 PHILIPS AVENT DOUBLE ELECTRIC BREAST PUKP NA HGX PHILIPS ELECTRONICS UK LIMITED SCF312

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other