BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE

    MDR report key: 2062569 · Received March 21, 2011

    Report

    Report Number
    1419937-2011-00042
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 19, 2011
    Report Date
    February 19, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN F/U WITH THE CUSTOMER, SHE INDICATED THAT SHE HAD JUST FINISHED PUMPING WHEN SHE HEARD A "FIZZING NOISE (LIKE LIQUID BUBBLING)" COMING FROM HER PUMP AND SOON REALIZED THAT IT WAS COMING FROM THE BATTERY PACK. SHE NOTICED A "BLACKISH-GREYISH" LIQUID COMING FROM THE BATTERY PACK, OPENED THE BATTERY PACK, CLEANED THE BATTERY PACK AND THE BATTERIES AND THE BATTERY PACK NEVER WORKED AGAIN AFTER THAT. SHE DOESN'T RECALL EVER GETTING THE BATTERY PACK WET AND SHE WASN'T SURE IF THERE WAS A BREACH OF ANY KIND IN ANY OF THE BATTERIES. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. SHE ORDERED A NEW BATTERY PACK AND THE PUMP IS WORKING FINE. SHE INDICATED THAT SHE WILL SEND THE BATTERY PACK IN FOR ANALYSIS/EVAL BUT SHE DISPOSED OF THE BATTERIES. AS OF THE DATE OF THIS REPORT, THE BATTERY PACK HAS NOT BEEN RECEIVED FROM THE CUSTOMER. CUSTOMERS ARE RESPONSIBLE FOR PROVIDING THEIR OWN AA ALKALINE BATTERIES TO PUT INTO THE MEDELA-PROVIDED BATTERY PACK. WITHOUT THE PRODUCT, AN ANALYSIS/ EVAL CANNOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT THAT THE BATTERIES WERE LEAKING ACID CAN BE NEITHER REFUTED NOR SUBSTANTIATED AND THE CAUSE OF THE ISSUE CANNOT BE DETERMINED. A CONCLUSION CANNOT BE MADE. WE WILL MONITOR FOR ADDITIONAL SIMILAR ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER PUMP BATTERIES (ALKALINE AA) "LEAKED BATTERY ACID INSIDE MY BATTERY PACK AND I HAVEN'T BEEN ABLE TO GET IT [THE BATTERY PACK] TO WORK SINCE." THE CUSTOMER DID NOT REPORT AN INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1