BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (UNKNOWN)

    MDR report key: 6907998 · Received October 2, 2017

    Report

    Report Number
    1419937-2017-00276
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 13, 2017
    Report Date
    September 29, 2017
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S EMAIL WAS RESPONDED TO WITH INFORMATION FOR PURCHASING A REPLACEMENT POWER SUPPLY AND WITH INSTRUCTIONS TO CONTACT MEDELA LLC VIA PHONE. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE ATTEMPTS TO CONTACT HER TO FOLLOW UP ON HER REPORT. THE ISSUE WITH A DAMAGED REV P POWER SUPPLY FOR THE PUMP IN STYLE DEVICE IS CURRENTLY BEING EVALUATED UNDER AN INVESTIGATION FOR (B)(4). A CONCLUSION REGARDING THIS ISSUE CANNOT BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE ISSUE WITH A DAMAGED PUMP IN STYLE REV P POWER SUPPLY FOR THE PUMP IN STYLE DEVICE WAS EVALUATED UNDER AN INVESTIGATION FOR COMPLAINT CATEGORY (B)(4), WHICH FOUND THAT BREACHES IN THE REV P POWER SUPPLY HOUSING ARE THE RESULT OF AN EXTERNAL LARGE FORCE IMPACT AND ARE NOT THE RESULT OF A MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE CUSTOMER ALLEGED VIA EMAIL TO MEDELA LLC THAT THE HOUSING ON THE POWER SUPPLY FOR HER PUMP IN STYLE BREAST PUMP HAD DETACHED, EXPOSING THE WIRES AND SHE COULD COMPLETELY SEE INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687060 PUMP IN STYLE (UNKNOWN) PUMP, BREAST, POWERED HGX MEDELA LLC PUMP IN STYLE (UNKNOWN) 9207010 REV P

    Patients

    Seq Age Sex Outcome Treatment
    1