BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBALT VIDEO BATON

    MDR report key: 3000160 · Received February 14, 2013

    Report

    Report Number
    9615393-2013-00064
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE RECEIVED THE DEVICE FOR FURTHER EVAL. DURING THE EVAL OF THE DEVICE SERVICE FOUND THE STEM SEPARATING FROM BASE WHICH IS CAUSING THE INTERMITTENT LOSS OF VIDEO. SERVICE CONFIRMED THE REPORTED FAILURE. A REPLACEMENT WAS ISSUED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED VERATHON INC. REGARDING A COBALT VIDEO BATON THAT IS HAVING INTERMITTENT LOSS OF VIDEO. THE CUSTOMER RETURNED THE DEVICE FOR FURTHER EVAL. NO PT INJURY WAS REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65355 COBALT VIDEO BATON NONE CCW VERATHON MEDICAL (CANADA) ULC. 0570-0185

    Patients

    Seq Age Sex Outcome Treatment
    1