BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE

    MDR report key: 1963803 · Received December 22, 2010

    Report

    Report Number
    1419937-2010-00094
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT TRANSFORMER WAS SHIPPED TO THE CUSTOMER AND THE ORIGINAL TRANSFORMER WAS RETURNED FOR EVAL/ANALYSIS. REFER TO EVAL SUMMARY, FOR DETAILS OF THE ANALYSIS/EVAL PERFORMED ON THE TRANSFORMER. IN SUMMARY, A BREACH IN THE OUTER INSULATION OF THE CORD WAS PRESENT AND COULD ALLOW FOR SPARKING, WHICH IF IN CONTACT WITH A MATERIAL WITH A LOW FLASH POINT, COULD POSE A FIRE HAZARD. THE BREACH IN THE INSULATION IS LIKELY THE RESULT OF THE MULTIPLE KINKS AND TWISTS EXAMINED IN THE CORD, WHICH ARE INDICATIVE OF USER HANDLING. CAPA (B)(4), APPROVED ON 11/18/2010, HAS BEEN INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/ MELTING ISSUES. ANY ADDITIONAL FOLLOW UP ACTIONS WILL BE ESTABLISHED AS A RESULT OF THE CAPA PROCESS. EVALUATION SUMMARY: A VISUAL EXAMINATION OF THE TRANSFORMER SHOWED NO SIGNS OF DEFORMATION ON THE PLASTIC HOUSING, BUT DID SHOW THAT THE CORD IS KINKED AND TWISTED AND THAT THERE IS A BREACH OF THE OUTER INSULATION APPROX 106 CM FROM THE STRAIN RELIEF. NO SIGNS OF EXCESSIVE HEAT COULD BE FOUND, BUT A FAINT ODOR OF HOT ELECTRONICS COULD BE DETECTED ON THE TRANSFORMER. THE TRANSFORMER WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 12.2V, WHICH IS WITHIN NORMAL RANGE AND INDICATES THAT THE TRANSFORMER IS WORKING PROPERLY. THE CORD WAS LIGHTLY MANIPULATED AROUND THE BREACH IN THE INSULATION AND IN ONE BEND, SPARKING WAS OBSERVED, THE RESISTANCE ACROSS THE AC MEASURED 60.1 OHMS WHICH IS NORMAL FOR THE TRANSFORMER AND INDICATES THAT THE INTERNAL THERMAL FUSE DID NOT BLOW. THE RESISTANCE ACROSS THE DC MEASURED 5.76 OHMS AND WITH LIGHT MANIPULATION AROUND THE BREACH IN THE INSULATION, THE RESISTANCE DROPPED BELOW 10 OHMS, WHICH INDICATES THAT THERE IS AN INTERMITTENT SHORT IN THE CORD. THE OUTER INSULATION WAS PEELED BACK AT THE BREACH AND A BREAK IN THE INNER INSULATION THAT SEPARATES THE POSITIVE AND NEGATIVE WIRES WAS OBSERVED. THIS COULD CONTRIBUTE TO AN INTERMITTENT SHORT. THE EXPOSED WIRES ON THE CORD ARE ON THE DC SIDE OF THE TRANSFORMER. THE OBSERVED SPARKING COULD POSE A POSSIBLE FIRE HAZARD IF THE SPARK CAME IN CONTACT WITH A MATERIAL WITH A LOW FLASH POINT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A SMALL FLAME THAT APPEARED IN THE MIDDLE OF THE POWER CORD FOR HER PUMP. SHE BLEW OUT THE SMALL FLAME AND COULD SEE EXPOSED COPPER WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE PUMP, BREAST, POWERED HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1