BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIBED

    MDR report key: 2062227 · Received March 17, 2011

    Report

    Report Number
    1419937-2011-00028
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    LBI
    PMA / PMN Number
    K962612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SENT THE BILIBED (SERIAL NUMBER (B)(4)) IN FOR REPAIR FOR AN EXPOSED WIRE ON THE POWER CORD. MEDELA'S SERVICE CTR SERVICED THE BILIBED ON (B)(4) 2010, REPLACING THE POWER CORD; HOWEVER, THE ORIGINAL POWER CORD WAS NOT RETAINED. THE POWER CORD IS DOUBLE INSULATED. IT IS UNCLEAR FROM THE CUSTOMER'S COMPLAINT AND FROM THE SERVICE CTR RECORDS WHETHER ONE OR BOTH LAYERS OF INSULATION WERE COMPROMISED. BASED ON AN ENGINEERING ASSESSMENT ABSENT AN EVAL OF THE ACTUAL POWER CORD INVOLVED IN THE COMPLAINT, THE POWER CORD WOULD HAVE 120VAC ELECTRICITY RUNNING THROUGH IT. A BREAK IN BOTH LAYERS OF THE INSULATION EXPOSING THE UNDERLYING METAL WIRES WOULD EXPOSE A CONSUMER TO VOLTAGE ABOVE THE LIMIT DESCRIBED IN UL 60601-1 SECTION 8.4.2C FOR ACCESSIBLE PARTS, WHICH POSES A SAFETY RISK. BECAUSE IT IS UNCLEAR WHETHER ONE OR BOTH LAYERS OF INSULATION WERE COMPROMISED, A MEDWATCH IS BEING FILED. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT EVALUATED, (IT WAS ONLY SERVICED); THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. WE WILL MONITOR FOR ADD'L SIMILAR ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER CORD FOR A BILIBED HAS EXPOSED WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILIBED LBI MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1