BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 1994369 · Received January 14, 2011

    Report

    Report Number
    1419937-2011-00003
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN F/U WITH THE CUSTOMER, SHE INDICATED THAT SHE DID NOT SEE A FIRE OR MELTING BUT DID NOTICE SPARKING. 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 A SHORT CIRCUIT WHICH CAUSED THE CORD TO SPARK, WHICH POSES A RISK SHOULD IT COME INTO CONTACT WITH A COMBUSTIBLE MATERIAL. CAPA CA10-049, APPROVED ON (B)(4) 2010, HAS BEEN INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES. ANY ADDITIONAL F/U ACTIONS WILL BE ESTABLISHED AS A RESULT OF THE CAPA PROCESS. EVAL SUMMARY: A VISUAL EXAM OF THE TRANSFORMER REVEALED NO DEFORMATION ON THE HOUSING. THE CORD APPEARED TO BE VERY TWISTED ALONG THE LENGTH WITH SEVERAL KINKS AND BENDS ALONG THE LENGTH AND A TEAR IN BOTH THE OUTER AND INNER CORD INSULATION AT THE STRAIN RELIEF, EXPOSING WIRES (ON THE DC SIDE) AND SHOWING SIGNS OF DISCOLORATION ON THE INNER INSULATION WHICH MAY INDICATE SIGNS OF SPARKING OR ELEVATED TEMPERATURES, THOUGH NOT CONCLUSIVE. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 11.9VDC, WHICH INDICATES THAT THE POWER SUPPLY IS WORKING PROPERLY. SPARKING WAS OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN AND THE CORD WAS MANIPULATED AT THE POINT OF THE STRAIN RELIEF. THE RESISTANCE ACROSS THE AC BLADES MEASURED 61.2 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW. THE RESISTANCE ACROSS THE DC PLUG MEASURED AT 0.7 OHMS WHICH INDICATES A SHORT IN THE DC CORD. THE BREAK IN THE INSULATION IS THE SOURCE OF THE SHORT CIRCUIT. THE EXPOSED WIRES ARE ON THE DC SIDE OF THE TRANSFORMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WERE EXPOSED WIRES ON THE CORD FOR HER PUMP'S POWER SUPPLY AND THAT SHE WAS SMOKING WHILE SHE WAS USING THE PUMP.

    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