BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMEDA PURELY YOURS DOUBLE ELECTRIC BREAST PUMP

    MDR report key: 3963489 · Received May 30, 2014

    Report

    Report Number
    3009974348-2014-00002
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 10, 2014
    Report Date
    May 30, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS TESTED ON (B)(4) 2014 PER AMEDA ENGINEERING TEST PROTOCOL. THE BREAST PUMP PASSED INVESTIGATION FUNCTIONALITY TESTING FOR VACUUM. NO SIGNS OF BATTERY ACID, BURNING, MELTING OR CHARRING INTERNAL TO THE BREAST PUMP WERE OBSERVED, HOWEVER BATTERY ACID WAS OBSERVED ON THE OUTSIDE OF THE PUMP HOUSING, BATTERY COMPARTMENT AREA, BATTERY COVER AND SILICONE TUBING. THE CURRENT MEASURED AT THE DC JACK WAS 0.973 AMPS USING THE RETURNED AC ADAPTER, THIS IS WITHIN SPECIFICATION. ZERO VOLTAGE WAS MEASURE ACROSS THE BATTERY CONTACTS WITH THE PUMP CONNECTED TO THE RETURNED AC ADAPTER, INDICATING THAT HE SWITCHING CIRCUITRY FUNCTIONED AS DESIGNED. THE PUMP SHOWS NO SIGNS OF THERMAL EVENT OF PUMP MALFUNCTION. ADDITIONAL TESTING CONFIRMED THAT BATTERIES MAY LEAK A DARK GRAY SUBSTANCE, E.G. BATTERY ACID, WHEN THE UPPER MIDDLE BATTERY IS PLACED INCORRECTLY, WITH THE POSITIVE AND NEGATIVE END REVERSED RELATIVE TO THE DIAGRAM IN THE PURELY YOURS BATTERY COMPARTMENT. AN ADDITIONAL WARMING REGARDING PROPER POSITIONING AND USE OF BATTERIES WILL BE UNDERTAKEN IN THE PURELY YOURS BREAST PUMP INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED BLACK LIQUID LEAKING FROM THE BASE OF THE PUMP. THE CONSUMER REPORTED PUMPING IN BED USING NEWLY REPLACED 6 AA BATTERIES AND AFTER 2 MINUTES OF PUMPING THE MOTOR MADE A POPPING NOISE. THE CONSUMER STATED SHE WAS HOLDING ONTO THE SIDE OF THE PUMP WHEN SHE NOTICED WARM BLACK FLUID LEAKING FORM THE PUMP BASE. THE CONSUMER REPORTED SHE FELT A SHOCK AND THE BLACK FLUID LEAKED ONTO HER CLOTHING, BEDDING AND THE BACK OF HER RIGHT HAND CAUSING A SMALL SUPERFICIAL BURN. THE CONSUMER REPORTED SHE TREATED HER BURN BY WASHING THE AREA AND PLACED ICE ON IT. THE CONSUMER DID NOT USE ANY ANTIBACTERIAL OR BURN OINTMENT AND DID NOT SEEK MEDICAL TREATMENT FOR THE BURN. THE CONSUMER STATED SHE HAD A 6 WEEK POST-PARTUM CHECKUP APPOINTMENT ON (B)(6) 2014 WITH HER OB/GYN WHO EXAMINED THE BURN, THE MD DID NOT OFFER ANY RECOMMENDATIONS FOR TREATMENT AS THE AREA WAS ALREADY HEALING, WAS NOT PAINFUL OR UNCOMFORTABLE. THE CONSUMER DECLINED THE OFFER OF A REPLACEMENT PUMP AS SHE HAD ALREADY PURCHASED ANOTHER PUMP BRAND. THE CONSUMER AGREED TO RETURN THE AFFECTED PUMP ALONG WITH PHOTOS OF THE STAINED ITEMS AND THE BACK OF HER HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319973 AMEDA PURELY YOURS DOUBLE ELECTRIC BREAST PUMP PURELY YOURS HGX AMEDA INC. 17075P UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other