BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

    MDR report key: 2854506 · Received November 29, 2012

    Report

    Report Number
    1419937-2012-00764
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER SUPPLY. IN F/U WITH THE CUSTOMER SHE CONFIRMED THAT THERE WAS NO SPARK, FIRE, FLAME, OR INJURIES SUSTAINED AS A RESULT OF THE ISSUE. CUSTOMER STATED THAT THE HOUSING HAD BEEN SEPARATING AND AFTER IT WAS DROPPED A SHUNT THE SIZE OF A NICKLE BROKE OFF. A PRODUCT EVAL REVEALED THAT THE TRANSFORMER HOUSING WAS CRACKED, 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 CONTACT. 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 THE PRODUCT ARE CURRENTLY BEING INVESTIGATED IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED. A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS UNPLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 14.06 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 53.38 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE POWER SUPPLY FOR HER BREAST PUMP WAS DROPPED AND IT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK HGX MEDELA, INC. 57062/9207010 REV L 0912

    Patients

    Seq Age Sex Outcome Treatment
    1