BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3972884 · Received April 28, 2014

    Report

    Report Number
    1419937-2014-00387
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    August 29, 2013
    Report Date
    August 29, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT TRANSFORMER. EVALUATION SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS NOT ABLE TO BE PLUGGED, SO THE VOLTAGE ACROSS THE DC PLUG WAS NOT MEASURED. RESISTANCE ACROSS THE DC PLUG MEASURED .765M, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. THE RESISTANCE ACROSS AC BLADES MEASURED AS 54.3 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW. THIS ISSUE WITH A DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE WAS ADDRESSED IN INVESTIGATION (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 FAIL PREMATURELY WHEN SUBJECTED TO NORMAL USE AND FORESEEABLE MISUSE. THE PACKAGING USED BY THE MANUFACTURER 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 STAKING OF THE SKIDS. THE SHIPPING PACKAGING STRENGTH HAS ALSO BEEN INCREASED TO FURTHER PROTECT THE TRANSFORMERS DURING SHIPPING. COMPLAINTS AGAINST THIS PRODUCT ARE CURRENTLY BEING MONITORED FOR EFFECTIVENESS OF THE ABOVE MENTIONED CORRECTIVE ACTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SVC THAT HER TRANSFORMER HAD A CRACK IN THE TRANSFORMER HOUSING. WHEN THE PRODUCT WAS EVALUATED BY QE IT WAS DETERMINED TO BE BREACH, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253604 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 REV M - 4912

    Patients

    Seq Age Sex Outcome Treatment
    1