BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2062236 · Received March 17, 2011

    Report

    Report Number
    1419937-2011-00030
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN F/U WITH THE CUSTOMER, HE STATED THAT THOUGH THE POWER SUPPLY DID NOT SMOKE, THERE WAS THE SMELL OF HEATING PLASTIC AND, THOUGH HE WAS NOT AWARE OF A BREACH IN THE TRANSFORMER HOUSING, THERE WAS SOME EVIDENCE OF MELTING AND THE CORD IS WARPED. HE ALSO INDICATED THAT HIS WIFE SUSTAINED A "SUPERFICIAL BURN" ON HER HAND. IN SUMMARY, A BREACH IN THE INNER INSULATION OF THE CORD AT THE STRAIN RELIEF WAS PRESENT AND RESULTED IN A SHORT CIRCUIT, WHICH CAUSED THE CORD TO HEAT UP AND BURN A HOLE IN THE TRANSFORMER. THIS IS A SAFETY RISK. CAPA (B)(4), APPROVED ON 11/18/2010, HAS BEEN INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES. ANY ADD'L F/U ACTIONS WILL BE ESTABLISHED AS A RESULT OF THE CAPA PROCESS. EVAL SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED A DEFORMATION ON THE TRANSFORMER HOUSING WITH AN APPROXIMATE 1 MM DIAMETER HOLE WITH A METAL WIRE PROTRUDING FROM THE HOLE (THE WIRE ALMOST COMPLETELY FILLS THE HOLE). A VISUAL EXAMINATION OF THE CORD REVEALED A KINK AT THE STRAIN RELIEF, A BREACH IN THE OUTER INSULATION APPROX 50 CM FROM THE DC PLUG AND NO SIGNS OF FIRE OR BURNING. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 0.05 VDC, WHICH INDICATES THAT THE POWER SUPPLY IS NOT PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 1.0 OHMS, WHICH INDICATES THAT THERE IS A SHORT IN THE DC CORD. SMOKE, FIRE AND SPARKING WERE NOT OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN. THE RESISTANCE ACROSS THE AC BLADES MEASURED AT 64.8 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER SUPPLY FOR HIS WIFE'S PUMP GOT "INCREDIBLY HOT AND SMELLED LIKE OZONE AND PLASTIC." THE CUSTOMER DID NOT REPORT ANY INJURIES.

    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