BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBALT VIDEO BATON

    MDR report key: 3000162 · Received February 14, 2013

    Report

    Report Number
    9615393-2013-00066
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 16, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE RECEIVED THE DEVICE FOR FURTHER EVAL. SERVICE CONFIRMED THE REPORTED EVENT AND A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED VERATHON INC. REGARDING A COBALT VIDEO BATON CABLE THAT IS MAKING THE VIEWABLE IMAGE DISAPPEAR WHEN ITS MOVED. ALSO, THE CUSTOMER INDICATED THAT THE CABLE SEEMS TO BE FRAYING AND NEEDS REPLACEMENT. THE DEVICE WAS RETURNED FOR FURTHER EVAL. THE REPORTED EVENT DID NOT OCCUR DURING USE WITH A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65390 COBALT VIDEO BATON NONE CCW VERATHON MEDICAL (CANADA) ULC. 0570-0185

    Patients

    Seq Age Sex Outcome Treatment
    1