BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

    MDR report key: 2864440 · Received December 5, 2012

    Report

    Report Number
    1419937-2012-00779
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 5, 2012
    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. IN FOLLOW UP WITH THE CUSTOMER ON (B)(6) 2012, THE CUSTOMER REPORTED THAT THEIR TRANSFORMER WAS CRACKED AND THEY TAPED IT TOGETHER TO PREVENT THE INNER ELECTRONICS FROM BEING EXPOSED. A PRODUCT EVAL REVEALED THAT THE TRANSFORMER HOUSING WAS BROKEN, EXPOSING INNER ELECTRONICS, WHICH IS A SAFETY RISK. THIS TYPE OF FAILURE IS TYPICALLY ASSOCIATED WITH DROPPING THE UNIT ONTO A HARD SURFACE OR OTHER TYPE OF SEVERE IMPACT. SEE EVAL SUMMARY FOR DETAILS OF TESTING/ANALYSIS. THE ORIGINAL DESIGN TESTING INVOLVED DROPPING THE UNIT FROM A 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 04/04/2011. COMPLAINTS AGAINST THIS PRODUCT ARE CURRENTLY BEING INVESTIGATED IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED. EVAL SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 13.96 VDC, WHICH IS NORMAL AND INDICATES THAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED OPEN, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. SMOKE, FIRE AND SPARKING WERE NOT OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN. THE RESISTANCE ACROSS THE AC BLADES MEASURED AS 54.29 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TRANSFORMER FOR THEIR PUMP IN STYLE DEVICE WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG HGX MEDELA, INC. 57036/9207010 REV L/ 1811

    Patients

    Seq Age Sex Outcome Treatment
    1