BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 2972158 · Received February 15, 2013

    Report

    Report Number
    1419937-2013-00104
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 26, 2013
    Report Date
    January 26, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE SENT THE CUSTOMER A REPLACEMENT POWER SUPPLY. IN F/U WITH THE CUSTOMER, SHE INDICATED THAT AFTER A COUPLE MONTHS OF USE, TWO SCREWS AT THE TOP OF THE TRANSFORMER HOUSING SHEARED OFF AND THE WHOLE BACK CAME OFF AS A RESULT. HOWEVER, SHE DID NOT WITNESS ANY SMOKE, FIRE OR SPARKING AND AN INJURY WAS NOT SUSTAINED AS A RESULT OF THE ISSUE. SHE ALSO INDICATED THAT SHE RETURNED THE PRODUCT, HOWEVER, AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT BEEN RECEIVED. 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 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 (B)(4) IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED. SHOULD THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE TRANSFORMER FOR HER BREAST PUMP "CRACKED AND FELL APART AND THE WIRES ARE EXPOSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69551 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 REV L - UNK

    Patients

    Seq Age Sex Outcome Treatment
    1