BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2193181 · Received July 21, 2011

    Report

    Report Number
    1419937-2011-00152
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT THERE WAS A FIRE "HALFWAY BETWEEN THE PLUG THAT GOES INTO THE PUMP AND THE OUTLET CONNECTOR, BUT IT DID NOT GET TO FULL FLAMES. IT WAS BRIGHT ORANGE/YELLOW LIKE RIGHT BEFORE IT FLAMES UP" AND THERE WAS MELTING AT THE SITE WHERE IT CAUGHT FIRE ALONG WITH A CRACK, BUT NOT THAT SHE HAD NOTICED PRIOR TO THE INCIDENT. SHE ALSO INDICATED THAT SHE DID WRAP THE CORD AROUND THE TRANSFORMER HOUSING, THAT HER REPLACEMENT POWER SUPPLY IS WORKING W/O ISSUE AND 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 A FIRE. AS A RESULT OF (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES, A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING. EVALUATION 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 TWISTING AND KINKING AND A BREACH IN THE INSULATION ALONG THE LENGTH OF THE CORD. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 12.7 VDC, WHICH IS NORMAL AND INDICATES THAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 0.76 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 58.5 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE POWER SUPPLY FOR HER BREAST PUMP "ACTUALLY CAUGHT ON FIRE." SHE PLUGGED IT IN BUT THE PUMP WOULD NOT PRODUCE SUCTION SO SHE CHECKED THE POWER SUPPLY AND SAW SMOKE. WHEN SHE UNPLUGGED IT SHE FOUND A BREAK IN THE CORD CONNECTION AND ACTUALLY SAW FLAMES COMING FROM THE BOX. THE CORD IS MELTED. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE BREAST PUMP HGX MEDELA, INC. 57063

    Patients

    Seq Age Sex Outcome Treatment
    1