BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (ITEM # UNK)

    MDR report key: 3070334 · Received April 17, 2013

    Report

    Report Number
    1419937-2013-00222
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER CORD WAS SENT TO THE CUSTOMER. IN FOLLOW-UP WITH THE CUSTOMER SHE REPORTED THAT HER TRANSFORMER SPARKED WHERE THE WIRES WERE EXPOSED AT THE JOINT OF THE ADAPTER PLUG AND WIRE. SHE ALSO NOTICED THAT THE TRANSFORMER HOUSING WAS MELTED. THE CUSTOMER DID NOT WITNESS ANY SMOKING OR FIRE AND NO INJURIES WERE REPORTED. THE PRODUCT INVOLVED IN THE COMPLAINT WAS RECEIVED AND EVALUATED. THE PRODUCT EVAL REVEALED THAT THE TRANSFORMER HOUSING IS MELTED (NO BREACH) AND THAT THERE ARE EXPOSED WIRES AND A SHORT IN THE CORD. AS A RESULT OF CAPA (B)(4), WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES, A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING. A VISUAL EXAM OF THE POWER SUPPLY REVEALED THE TRANSFORMER EXPOSED WIRES AND MELTING (NO BREACH). THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 0.09 VDC, THERE IS A SHORT IN THE DC CORD, WHICH INDICATES THAT THE POWER SUPPLY IS PRODUCING THE INCORRECT VOLTAGE. SMOKE, FIRE AND SPARKING WERE NOT OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT HER TRANSFORMER HAS EXPOSED WIRES AND THAT IT DOES NOT POWER ON HER PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166521 PUMP IN STYLE (ITEM # UNK) HGX MEDELA, INC. 57XXX/9207010 17B/PRIOR TO REV L

    Patients

    Seq Age Sex Outcome Treatment
    1