BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2093585 · Received April 6, 2011

    Report

    Report Number
    1419937-2011-00058
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT SHE DID NOT SEE A FIRE OR SMOKING, BUT SAW A SPARK AT THE STRAIN RELIEF. THERE WAS NOT A BREACH IN THE TRANSFORMER HOUSING, BUT THERE WERE EXPOSED WIRES ON THE CORD AT BOTH THE STRAIN RELIEF AND IN THE MIDDLE OF THE CORD, THOUGH NO SIGNS OF MELTING. 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 RETURN THE ORIGINAL POWER SUPPLY. HOWEVER, AS OF THE DATE OF THIS REPORT, THE POWER SUPPLY HAS NOT BEEN RECEIVED. 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. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED. AS A RESULT OF (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES, A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON (B)(4) 2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER SUPPLY FOR HER PUMP "STOPPED WORKING AND IT ALSO SPARKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1