BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BP ADVANCED PERSONAL DOUBLE

    MDR report key: 4339924 · Received December 9, 2014

    Report

    Report Number
    1419937-2014-00906
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Date of Event
    November 17, 2014
    Report Date
    December 3, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED SPARKING FROM EXPOSED WIRES ON THE TRANSFORMER. SHE DID NOT REPORT OF ANY INJURY OR FIRE. PRODUCT WAS RECEIVED AND EVALUATED ON 12/03/2014 BY QE. AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES, A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING. A VISUAL EXAMINATION OF THE CORD REVEALED THERE WERE EXPOSED WIRES ON CORD NEAR BASE OF HOUSING AND THE CORD WAS TWISTED. THE POWER SUPPLY WAS UNSAFE TO PLUG IN SO THE VOLTAGE ACROSS THE DC PLUG WAS NOT MEASURED. RESISTANCE ACROSS THE AC BLADES MEASURED AS 58.2 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE TRANSFORMER WIRES OF HER ADVANCED PERSONAL DOUBLE BREAST PUMP HAD SPARKED WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792854 BP ADVANCED PERSONAL DOUBLE HGX HGX MEDELA, INC. 9207010/57065 PRIOR TO REV L/1111

    Patients

    Seq Age Sex Outcome Treatment
    1