BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 6853349 · Received September 8, 2017

    Report

    Report Number
    1717344-2017-05873
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Date of Event
    May 9, 2017
    Report Date
    August 24, 2017
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884524001562
    PMA / PMN Number
    K944602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED FORCEFX-8C GENERATOR WAS RECEIVED, AND EVALUATION OF THE RETURNED SAMPLE CONFIRMED AN REM ALARM ISSUE. TESTING OF THE DEVICE FOUND THE UPPER REM RANGE IS EXCEEDED BEFORE THE DEVICE WILL ALARM. THE INVESTIGATION ISOLATED THE FAILURE TO THE REM FREQUENCY, BUT A ROOT CAUSE WAS NOT IDENTIFIED. THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THE REM FREQUENCY WAS ADJUSTED TO THE HIGHEST AND A NEW RECALIBRATION WAS PERFORMED TO ADDRESS THE CONDITION. AFTER THESE ADJUSTMENTS, THE REM WOULD ALARM WITHIN SPECIFICATIONS. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE REM ALARM RANGE EXCEEDED SPECIFICATIONS. THE DEVICE DID NOT ALARM WHEN SPECIFICATIONS WERE EXCEEDED. THE ISSUE OCCURRED DURING SERVICING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631409 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER FORCEFX-8C 10884524001562

    Patients

    Seq Age Sex Outcome Treatment
    1