BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2001581 · Received January 26, 2011

    Report

    Report Number
    1419937-2011-00009
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT SHE DID NOT SEE A FIRE, BUT DID SEE MELTING AND SPARKING. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE, THAT HER REPLACEMENT POWER SUPPLY IS WORKING WITHOUT ISSUE AND THAT SHE WOULD SEND THE ORIGINAL POWER SUPPLY IN FOR EVAL/ANALYSIS. HOWEVER, AFTER REPEATED FOLLOW-UPS WITH THE CUSTOMER TO OBTAIN THE PRODUCT, IT HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. SPARKING IS INDICATIVE OF AT LEAST ONE SHORT IN THE DC CORD, WHICH DOES NOT POSE AN ELECTROCUTION RISK SINCE IT IS ON THE DC SIDE OF THE TRANSFORMER; HOWEVER, SPARKING POSES A RISK SHOULD IT COME IN CONTACT WITH A COMBUSTIBLE MATERIAL. AS THE ORIGINAL PRODUCT IS NOT AVAILABLE FOR EVAL/ANALYSIS, NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT CAN BE MADE. SHOULD THE PRODUCT BECOME AVAILABLE, AN EVAL WILL BE PERFORMED AND A SUPPLEMENTAL MEDWATCH SUBMITTED AT THAT TIME. CAPA CA10-049, APPROVED ON (B)(4) 2010, HAS BEEN INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES. ANY ADDITIONAL FOLLOW UP ACTIONS WILL BE ESTABLISHED AS A RESULT OF THE CAPA PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER SUPPLY FOR HER PUMP SPARKED AND MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED NONE HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1