BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2211657 · Received August 5, 2011

    Report

    Report Number
    1419937-2011-00160
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER FOR ADD'L COMPLAINT INFO, BUT ALL WERE UNSUCCESSFUL. THE CUSTOMER DID, HOWEVER, RETURN THE POWER SUPPLY. IN SUMMARY, A SHORT CIRCUIT CAUSED THE TRANSFORMER TO HEAT UP, RESULTING IN A BREACH IN THE HOUSING. A BREACH IN THE TRANSFORMER HOUSING IS A SAFETY RISK. 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 BOTH THE INNER AND OUTER INSULATION ON THE DC OUTPUT CORD WAS BREACHED AT THE STRAIN RELIEF. A METAL WIRE APPROX 1.5 MM IN DIAMETER WAS PROTRUDING APPROX 1.75 MM ABOVE THE HOUSING SURFACE. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 0.00VDC, WHICH INDICATES THAT THE POWER SUPPLY IS NOT PRODUCING THE CORRECT VOLTAGE. NO SMOKE, FIRE, OR SPARKING WAS OBSERVED. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 0.7 OHMS, WHICH INDICATES THAT THERE IS A SHORT IN THE DC CORD. THE RESISTANCE ACROSS THE AC BLADES MEASURED OVER LIMIT, WHICH INDICATES THAT THE THERMAL DID BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SVC THAT HER TRANSFORMER HAD EXPOSED WIRES. THE PUMP WAS WORKING WITH THE BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE BREAST PUMP HGX MEDELA, INC. 57018W

    Patients

    Seq Age Sex Outcome Treatment
    1