BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 9607880 · Received January 20, 2020

    Report

    Report Number
    3007305485-2019-00444
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    December 23, 2019
    Report Date
    February 6, 2020
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF DEVICE 7-900-115 FOUND THAT UNIT POWER UP CORRECTLY AND LFC WAS "0" WHICH MEANS THAT UNIT HAS NEVER DECLARED FAULT. THE EVALUATION WAS PERFORMED AND ALL DATA MET SPECIFICATIONS. UNIT PASSED FINAL TEST. THE SERVICE HISTORY WAS REVIEWED AND FOUND THAT THE DEVICE WAS SERVICED ON DECEMBER 12, 2019. A DHR REVIEW FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS REPORTED EVENT. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 4 COMPLAINTS REGARDING 4 DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME (B)(4) HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; IN ALL ELECTRICAL DEVICES WHERE A CURRENT IS EMITTED FROM THE INSTRUMENT, THE CURRENT MUST HAVE A RETURN PATH. THE RETURN PAD FOR MONOTERMINAL APPLICATIONS IS THROUGH THE PATIENT'S BODY, TO THE GROUND AND BACK TO THE INSTRUMENT. IN THIS MODE, IF ANY PORTION OF THE PATIENT'S BODY COMES IN CONTACT WITH A GROUNDED METAL OBJECT, SUCH AS A CHAIR OR METAL RAIL, THE CURRENT WILL TAKE THE PATH OF THE LEAST RESISTANCE AND A SLIGHT SHOCK MAY BE FELT. TO MINIMIZE THE POSSIBILITY OF SHOCKING DURING MONOTERMINAL APPLICATIONS: DO NOT LET THE PATIENT TO COME IN CONTACT WITH ANY GROUNDED METAL OBJECTS, POSITION THE ELECTRODE ON OR CLOSE TO THE PATIENT BEFORE ACTIVATING THE OUTPUT THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE REPORT DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION AND THE COMPLAINT INVESTIGATION IS ONGOING. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 7-900-115, HYFRECATOR 2000, SHOCKED BOTH THE PATIENT (AN INFANT) AND THE GRANDMOTHER HOLDING THE PATIENT. THE PATIENT RECEIVED A SMALL BURN WHERE THE GRANDMOTHER WAS TOUCHING THE BABY. NO GROUNDING PAD WAS USED, IT WAS USED ON A MONOPOLAR MODE, THERE WAS NO NEED FOR MEDICAL INTERVENTION. THE CUSTOMER ADMITS IT WAS USER ERROR. THIS REPORT IS BEING RAISED AS PATIENT INJURY DUE TO THE UNKNOWN DEGREE OF BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71498 HYFRECATOR 2000, 115V HYFRECATOR EQUIPMENT GEI CONSOLIDATED MEDICAL EQUIPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other