BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 1993819 · Received January 13, 2011

    Report

    Report Number
    1419937-2011-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN A F/U WITH THE CUSTOMER, SHE INDICATED THAT SHE DID NOT SEE A FIRE OR SPARK BUT DID NOTICE SMOKE. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE AND THAT THE REPLACEMENT POWER SUPPLY IS WORKING WITHOUT ISSUE. IN SUMMARY, A BREACH IN THE OUTER INSULATION OF THE CORD AT THE STRAIN RELIEF WAS PRESENT AND RESULTED IN AN INTERMITTENT SHORT CIRCUIT WHICH CAUSED THE CORD TO HEAT UP AND SHOW SIGNS OF MELTING AND BURNING. CAPA CA10-049, APPROVED ON (B)(4) 2010, HAS BEEN INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES. ANY ADD'L F/U ACTIONS WILL BE ESTABLISHED AS A RESULT OF THE CAPA PROCESS. EVAL SUMMARY: A VISUAL EXAMINATION OF THE TRANSFORMER REVEALED NO DEFORMATION ON THE HOUSING. THE CORD APPEARED TO BE SLIGHTLY TWISTED ALONG THE LENGTH WITH A TEAR IN BOTH THE OUTER AND INNER CORD INSULATION AT THE STRAIN RELIEF, EXPOSING WIRES (ON THE DC SIDE) AND SHOWING SIGNS OF MELTING AND BURNING. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 12.1VDC, WHICH INDICATES THAT THE POWER SUPPLY IS WORKING PROPERLY. NO SPARKS OR SMOKE WAS OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN. THE RESISTANCE ACROSS THE AC BLADES MEASURE 59.6 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW. THE RESISTANCE ACROSS THE DC PLUG MEASURED AT OVER 3.6 OHMS. WHEN THE CORD WAS MANIPULATED AROUND THE BREAK IN THE INSULATION, THE RESISTANCE WOULD IN SOME CASES DROP BELOW 1 OHM, WHICH INDICATES AN INTERMITTENT SHORT IN THE DC CORD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER PUMP WOULD NOT TURN ON WITH THE POWER SUPPLY AND THAT THE POWER SUPPLY WAS SMOKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED NONE HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1