BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2211656 · Received August 5, 2011

    Report

    Report Number
    1419937-2011-00159
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 6, 2011
    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

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. IN F/U WITH THE CUSTOMER, SHE INDICATED THAT SHE DID NOT SEE FIRE OR SMOKE AND THAT THERE IS NO BREACH IN THE TRANSFORMER HOUSING, BUT SHE DID SEE SPARKING AND EXPOSED WIRES AT THE STRAIN RELIEF WHERE THERE APPEARED TO BE MELTING. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. IN SUMMARY, A BREACH IN THE INSULATION ON THE DC OUTPUT CORD WAS PRESENT, EXPOSING WIRES AND RESULTING IN A SHORT WHICH COULD CAUSE SPARKING. AS A RESULT OF CAPA CA10-049 WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES, A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON (B)(4) 2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING. EVAL SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED NO DEFORMATION ON THE TRANSFORMER HOUSING AND NO HOLES OR OPENINGS. A VISUAL EXAMINATION OF THE CORD REVEALED THE INSULATION HAD MELTED AT THE STRAIN RELIEF, EXPOSING WIRES. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 0.4 VDC, WHICH INDICATES THE POWER SUPPLY IS NOT PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 0.79 OHMS, WHICH INDICATES THAT THERE IS 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 59.6 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SVC THAT THE POWER SUPPLY FOR HER PUMP STARTED GETTING HOT AND BEGAN SPARKING. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE BREAST PUMP HGX MEDELA, INC. 57027

    Patients

    Seq Age Sex Outcome Treatment
    1