BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3063597 · Received April 12, 2013

    Report

    Report Number
    1419937-2013-00210
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN A FOLLOW UP WITH THE CUSTOMER, THE CUSTOMER REPLIED THAT SHE DID NOT WITNESS ANY SMOKE, FIRE, SPARKING, OR MELTING. THE CUSTOMER STATED THAT THE TRANSFORMER HOUSING CRACKED STARTING AT THE BASE WHERE THE CORD EXITS AND ALSO AT THE TOP TWO CORNERS. SHE 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 FOLLOW UP REPORT WILL BE FILED AT THAT TIME. THIS ISSUE WITH A DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE WAS ADDRESSED IN INVESTIGATION IR (B)(4). THE INVESTIGATION FOUND THAT THE TRANSFORMERS ARE BEING DAMAGED DURING SHIPMENT FROM THE MANUFACTURER TO MEDELA. THIS DAMAGE IS CAUSING THE PLASTIC HOUSING TO FALL PREMATURELY WHEN SUBJECTED TO NORMAL USE AND FORESEEABLE MISUSE. THE PACKAGING USED BY THE MFR TO SHIP THE TRANSFORMERS TO MEDELA IS NOT ROBUST ENOUGH TO HANDLE ALL OF THE POTENTIAL SHIPPING, HANDLING, AND ABUSE CONDITIONS THAT COULD ARISE FROM LOGISTICS OF THE CONSOLIDATION PROCESS. AS A RESULT OF THE INVESTIGATION, THE SHIPPING AND CONSOLIDATION PROCESS HAS BEEN MODIFIED TO REDUCE THE HANDLING AND POTENTIAL FOR DOUBLE STACKING OF THE SKIDS. THE SHIPPING PACKAGING STRENGTH HAS ALSO BEEN INCREASED TO FURTHER PROTECT THE TRANSFORMERS DURING SHIPPING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE HOUSING IS FALLING APART, WHICH INDICATES A BREACH IN TRANSFORMER HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159262 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 1212/REV M

    Patients

    Seq Age Sex Outcome Treatment
    1