BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3013226 · Received March 15, 2013

    Report

    Report Number
    1419937-2013-00151
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. ATTEMPTS TO RETRIEVE THE PRODUCT HAVE BEEN UNSUCCESSFUL. IN FOLLOW UP WITH THE CUSTOMER, THE CUSTOMER STATED THAT THE TRANSFORMER HOUSING CRACKED ON THE TOP. THE CUSTOMER STATED THAT SHE DID NOT SEE ANY SPARKING, SMOKING, FIRE OR MELTING. THE CUSTOMER ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. 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. THIS TYPE OF FAILURE IS TYPICALLY ASSOCIATED WITH DROPPING THE UNIT ONTO 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 SECOND 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 LEASE 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 (B)(4) IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT HER TRANSFORMER IS FALLING APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110445 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA INC 57063/9207010 0912/REV L

    Patients

    Seq Age Sex Outcome Treatment
    1