BEUDAMED
    FDA Adverse Event Summary report: N

    OR INTEGRATION SYSTEM

    MDR report key: 3759163 · Received April 18, 2014

    Report

    Report Number
    1000404456-2014-00001
    Date Received
    April 18, 2014
    Date of Event
    February 11, 2014
    Report Date
    April 18, 2014
    Manufacturer
    VTS MEDICAL SYSTEMS, LLC
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURIES TO HOSPITAL STAFF OR PATIENT REPORTED. A STERIS SURGICAL SPECIALIST ARRIVED ONSITE AND FOUND THE CABLE WAS PINCHED/DAMAGED WITHIN THE MONITOR ARM TO THE 3RD PARTY MONITOR REQUIRED REPLACEMENT. THE TECHNICIAN REPAIRED THE SYSTEM AND RETURNED IT TO SERVICE; NO FURTHER ISSUES HAVE BEEN REPORTED. THE SURGICAL SPECIALIST IN-SERVICED THE BIOMEDS AND HOSPITAL STAFF ON THE PROPER USE AND OPERATION OF THE INTEGRATION SYSTEM. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    REFERENCE MEDWATCH (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238469 OR INTEGRATION SYSTEM OR INTEGRATION SYSTEM KQM VTS MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1