BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPOSAL SAFETY STATION NON-STERILE

    MDR report key: 6798548 · Received August 16, 2017

    Report

    Report Number
    0001954182-2017-00016
    Event Type
    Malfunction
    Date Received
    August 16, 2017
    Date of Event
    February 2, 2017
    Report Date
    August 16, 2017
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS BEING REPORTED BY ZIMMER BIOMET AS (B)(4). DEVICE PROBLEM: "DEVICE EMITS ODOR" IS FOR BURNING SMELL. THE PREVIOUS REPAIR REPORT FOR THE TRANSPOSAL SAFETY STATION, SERIAL (B)(4) WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD) OR ANY OTHER ISSUES WITH THE REPAIR. THE REPORTED EVENT WAS CONFIRMED BY THE SERVICE TECHNICIAN WHO PERFORMED THE REPAIR. GSE BIO-MEDICAL SERVICES WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE TECHNICIAN FOUND THAT BOOSTER PUMP WAS LEAKING AND MAIN FUSE WAS SHORTED. HE REPLACED THE FUSE AND THE BOOSTER PUMP THEN VERIFIED THAT THE DEVICE WAS FUNCTIONING AS INTENDED. THE UNIT WAS THEN RETURNED TO SERVICE WITHOUT INCIDENT. THE UNIT WAS TESTED, INSPECTED, AND REPAIRED. WHILE THE SERVICE TECHNICIAN CONFIRMED THAT THE UNIT WAS HAVING A BURNING SMELL DUE TO BOOSTER PUMP LEAK AS WELL AS A SHORT MAIN FUSE AND NOTED THAT THE CART WAS FUNCTIONING AS INTENDED AFTER THE TECHNICIAN REPLACED THE FUSE AND THE BOOSTER PUMP, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED WHAT ACTUALLY CAUSED THE REPORTED EVENT. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. PRODUCT EVALUATED BY EXTERNAL CONTRACTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY STATION HAS HAD A BURNING SMELL FOR SOME TIME. IT SHUT DOWN DURING A CYCLE AND WOULD NOT POWER BACK ON. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579652 TRANSPOSAL SAFETY STATION NON-STERILE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1