BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2062182 · Received March 17, 2011

    Report

    Report Number
    1419937-2011-00031
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN F/U WITH THE CUSTOMER, SHE STATED THAT SHE WITNESSED A SPARK, FIRE AND SMOKE SHORTLY AFTER SHE FINISHED PUMPING AND THAT THERE IS EVIDENCE ON THE CORD. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. EVAL SUMMARY, FOR DETAILS OF THE ANALYSIS/EVAL PERFORMED ON THE POWER SUPPLY. THE RESULTS OF THE ANALYSIS/EVAL COULD NEITHER REFUTE NOR SUBSTANTIATE THE CUSTOMER'S STATEMENT THAT THE CORD STARTED ON FIRE. A CONCLUSION AS TO THE CAUSE OF THE ISSUE CANNOT BE MADE. 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 EXAMINATION OF THE POWER SUPPLY REVEALED NO DEFORMATIONS. A VISUAL EXAMINATION OF THE CORD REVEALED A KINK AT THE STRAIN RELIEF, EXPOSED WIRES AT APPROX 36 CM FROM THE DC PLUG, MELTING OF OUTER INSULATION AND SOME DISCOLORATION OF THE UNDERLYING COPPER WIRES. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 12.1 VDC, WHICH INDICATES THAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT GREATER THAN 0.6 MEGA-OHMS, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. SMOKE, FIRE AND SPARKING WERE NOT OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN. THE RESISTANCE ACROSS THE AC BLADES MEASURED AT 60.5 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER SUPPLY FOR HER PUMP "MADE A FLARE AND ALMOST STARTED ON FIRE." THE CUSTOMER DID NOT REPORT ANY INJURIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1