BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR

    MDR report key: 6700140 · Received July 11, 2017

    Report

    Report Number
    0001954182-2017-00007
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    May 23, 2017
    Report Date
    July 10, 2017
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BEING REPORTED BY ZIMMER BIOMET AS (B)(4). PMA/510K NUMBER : K081047; K123188; K133786. THE ULTRA DUO HIGH FLUID CART WAS 46 MONTHS OLD AT THE TIME THIS COMPLAINT WAS GENERATED. THE PREVIOUS REPAIR REPORT WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD) OR ANY OTHER ISSUES WITH THE REPAIR. THE PREVIOUS REPAIR REPORT REVIEW FOUND NO ISSUES WITH THE DEVICE AFTER REPAIR AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. THE DEVICE WAS NOTED TO HAVE BEEN PREVIOUSLY REPAIRED 4 TIMES, THE PREVIOUS REPAIR BEING FOR THE RIGHT CYLINDER NOT DRAINING ON 19 JULY 2016. THE VALVE PACK WAS NOT ASSOCIATED WITH THE CURRENT REPAIR SERVICE, SO THE PREVIOUS REPAIR WAS A NON-RELATED ISSUE. THE COMPLAINT HISTORY REVIEW WAS NOT REQUIRED SINCE THE REPAIR TECHNICIAN COULD NOT REPRODUCE THE REPORTED EVENT OR FIND ANY OTHER ISSUES WITH THE DEVICE. ON (B)(6) 2017, IT WAS REPORTED FROM (B)(6) THAT THE UNIT HAD A SMOKEY ELECTRICAL BURNING SMELL. THE EVENT TIMING WAS UNKNOWN. THE ZIMMER BIOMET INSTALLATION TECHNICIAN WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. ON (B)(6) 2017, THE TECHNICIAN FOUND NO ISSUES WITH THE CART. THERE WAS NO SMELL COMING FROM THE UNIT. THE TECHNICIAN THEN VERIFIED THAT THE DEVICE WAS FUNCTIONING AS INTENDED. THE UNIT WAS THEN RETURNED TO SERVICE WITHOUT INCIDENT. NO REPAIR CHECKLIST WAS NOT REQUIRED PER CRM. THE REPAIR TECHNICIAN COULD NOT REPRODUCE THE REPORTED EVENT OR FIND ANY OTHER ISSUES WITH THE DEVICE. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 1

    IT IS REPORTED THE UNIT HAD A SMOKEY ELECTRICAL BURNING SMELL. NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483062 ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A

    Patients

    Seq Age Sex Outcome Treatment
    1