BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (ITEM # UNK)

    MDR report key: 3072647 · Received April 19, 2013

    Report

    Report Number
    1419937-2013-00224
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER WAS SENT TO THE CUSTOMER. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER. THERE WAS NOT RESPONSE FROM THE CUSTOMER TO FOLLOW UP QUESTIONS. 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. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WIRES ON THEIR PUMP IN STYLE TRANSFORMER WERE FRAYED AND THAT THEY SAW SPARKING FROM THE EXPOSED WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169419 PUMP IN STYLE (ITEM # UNK) HGX MEDELA, INC. 9207010 / UNKNOWN 10I

    Patients

    Seq Age Sex Outcome Treatment
    1