BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE MEDICAL ASSISTANCE BREAST PUMP

    MDR report key: 2922275 · Received January 15, 2013

    Report

    Report Number
    1419937-2013-00030
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN F/U,THE CUSTOMER INDICATED THAT THE TRANSFORMER HOUSING WAS CRACKED WHEN SHE RECEIVED IT AND A PORTION OF THE PLASTIC EVENTUALLY BROKE OFF, EXPOSING INNER ELECTRONICS. SHE DID NOT EXPERIENCE ANY SMOKE, FIRE OR SPARKING AND AN INJURY WAS NOT SUSTAINED AS A RESULT OF THE ISSUE. SHE ALSO INDICATED THAT SHE RETURNED THE POWER SUPPLY, BUT AS OF THE DATE OF THIS REPORT, IT HAS NOT BEEN RECEIVED. THOUGH THE PRODUCT HAS NOT BEEN RECEIVED AND EVALUATED, 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 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 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 OPEN WHEN SHE RECEIVED THE PUMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22106 PUMP IN STYLE MEDICAL ASSISTANCE BREAST PUMP HGX MEDELA, INC. 57038/9207010 REV L - 2011

    Patients

    Seq Age Sex Outcome Treatment
    1