BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

    MDR report key: 3002401 · Received March 8, 2013

    Report

    Report Number
    1419937-2013-00137
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. CONTACT WAS NOT MADE WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. THIS TYPE OF FAILURE IS TYPICALLY ASSOCIATED WITH DROPPING THE UNIT ONTO A HARD SURFACE OR OTHER TYPE OF SEVERE IMPACT. THE ORIGINAL DESIGN TESTING INVOLVED DROPPING THE UNIT FROM 1.0 M HEIGHT PER UL2601-1 2ND EDITION. PRODUCTION SAMPLES WERE DROPPED THREE TO FIVE TIMES FROM A HEIGHT OF 1.0 M AND THE HOUSINGS SHOWED DAMAGE AND CRACKING (ONLY AFTER AT LEAST THREE DROPS). THIS PRODUCT WAS RELEASED AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES FOR WHICH A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/4/2011. COMPLAINTS AGAINST THIS PRODUCT ARE CURRENTLY BEING INVESTIGATED (B)(4) IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO CUSTOMER SERVICE TO REPORT THAT WHEN SHE TRIED TO UNPLUG THE PUMP IN STYLE TRANSFORMER FROM THE WALL IT FELL APART AND GENERATED A BIG SPARK. CUSTOMER ADVISED NO FIRE. NO INJURY BUT SHORTED THE ELECTRICAL CIRCUIT IN HOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100462 PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG HGX MEDELA, INC. 57036/9207010 REV M

    Patients

    Seq Age Sex Outcome Treatment
    1