BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE COBALT AVL MONITOR

    MDR report key: 2972591 · Received February 15, 2013

    Report

    Report Number
    9615393-2013-00092
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COULD NOT DUPLICATE THE ISSUE WHEN HE CONTACTED US TO REPORT PROBLEM. HE STATED THAT HE WOULD CONTACT US IN THE FUTURE IF THE ISSUE OCCURRED AGAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONITOR DIDN'T TURN OFF EARLIER THAT DAY BUT WAS POWERING ON AND OFF WHEN HE CALLED. HE COULD NOT DUPLICATE THE ISSUE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69406 GLIDESCOPE COBALT AVL MONITOR NONE CCW VERATHON MEDICAL (CANADA) ULC 0570-0314

    Patients

    Seq Age Sex Outcome Treatment
    1