BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (ITEM # UNK)

    MDR report key: 2972153 · Received February 15, 2013

    Report

    Report Number
    1419937-2013-00102
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN F/U WITH THE CUSTOMER, THE CUSTOMER INDICATED THAT THEIR TRANSFORMER HAD CRACKED AND THAT IT COULD COME APART INTO TWO PIECES. THE CUSTOMER ALSO INDICATED THAT SHE WOULD RETURN THE PRODUCT. HOWEVER, AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT BEEN RECEIVED. SHOULD THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILED AT THAT TIME. THOUGH THE PRODUCT HAS NOT BEEN RECEIVED AND EVALUATED, THIS TYPE OF FAILURE IS TYPICALLY ASSOCIATED WITH DROPPING THE UNIT UNTO A HARD SURFACE OR OTHER TYPE OF SEVERE IMPACT. THE ORIGINAL DESIGN TESTING INVOLVED DROPPING THE UNIT FROM A HEIGHT 1.0 M 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 (B)(4) IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PIECE OF THE TRANSFORMER HOUSING FOR THEIR PUMP. IN STYLE DEVICE HAD FALLEN OFF. THE CUSTOMER REPORTED IN F/U THAT THE ENTIRE TRANSFORMER COULD COME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69495 PUMP IN STYLE (ITEM # UNK) HGX MEDELA, INC. UNKNOWN / 9207010 REV M

    Patients

    Seq Age Sex Outcome Treatment
    1