BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPOSAL SAFETY STATION

    MDR report key: 7010887 · Received November 8, 2017

    Report

    Report Number
    0001526350-2017-00835
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    November 7, 2017
    Report Date
    December 17, 2017
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FLH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). DEVICE EMITS ODOR: THERE WAS A BURNING SMELL FROM THE UNIT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, BUT WILL BE EVALUATED BY AN EXTERNAL CONTRACTOR. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. THE PREVIOUS REPAIR RECORD FOR TRANSPOSAL SAFETY STATION SERIAL NUMBER (B)(4) WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD) OR ANY OTHER ISSUES WITH THE REPAIR. THE PREVIOUS REPAIR RECORD REVIEW FOUND NO ISSUES WITH THE DEVICE AFTER REPAIR AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. THE REPORTED EVENT WAS CONFIRMED BY THE SERVICE TECHNICIAN WHO PERFORMED THE REPAIR PER CL-REPAIR TPSS REV 4. ON (B)(6) 2017, IT WAS REPORTED FROM (B)(6) THAT THE UNIT HAS A BURNING SMELL AND IS NOT POWERING ON. CRAWFORD DIVERSIFIED SERVICES, INC. WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. ON (B)(6) 2017, THE TECHNICIAN FOUND BLEACH FLOW SENSOR SMOKING, LED ON PRESSURE TRANSDUCER IS NOT LIGHTING UP AND RIGHT CANISTER IS STILL NOT WORKING. HE REPLACED THE BLEACH FLOW SENSOR (PART#91220), RIGHT CANISTER SWITCH (PART#90060 AND LOT CODE#0025836) AND CANISTER SWITCH BOARD AND THEN VERIFIED THAT THE DEVICE WAS FUNCTIONING AS INTENDED. THE CART WAS THEN RETURNED TO SERVICE WITHOUT INCIDENT. THE UNIT WAS TESTED, INSPECTED, AND REPAIRED AS PER CL-REPAIR TPSS REV. 4. SERVICE WORK ORDER (B)(4) ON (B)(6) 2017. THE ROOT CAUSE OF THE REPORTED EVENT OF BURNING SMELL FROM THE UNIT WAS DUE TO BLEACH FLOW SENSOR SMOKING AND THE ROOT CAUSE OF THE REPORTED EVENT OF UNIT NOT POWERING ON WAS DUE TO MALFUNCTIONED LED ON PRESSURE TRANSDUCER. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER BLEACH FLOW SENSOR, RIGHT CANISTER SWITCH AND CANISTER SWITCH BOARD WERE REPLACED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. THE REPLACEMENT OF THE CANISTER SWITCH AND CANISTER SWITCH BOARD WERE NOT AFFILIATED WITH THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD A BURNING SMELL AND WAS NOT POWERING ON. THE EVENT OCCURRED DURING CLEANING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789595 TRANSPOSAL SAFETY STATION WASHER OF BODY WASTE RECEPTACLES FLH ZIMMER SURGICAL, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1