BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE

    MDR report key: 7837183 · Received August 31, 2018

    Report

    Report Number
    0001954182-2018-00059
    Event Type
    Malfunction
    Date Received
    August 31, 2018
    Date of Event
    August 7, 2018
    Report Date
    October 31, 2018
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE SERIOUS INJURY AND HAS NOT BEEN PREVIOUSLY REPORTED AS A SERIOUS INJURY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    THIS HAS CHANGED TO NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K081047; K123188; K133786. THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS LEAKING AND THERE WAS A CRACKED BOTTOM PLATE. THE EVENT OCCURRED DURING SURGERY. NO MEDICAL INTERVENTION, NO BACKFLOW, NO DELAY REPORTED . ALTERNATIVE DEVICE WAS USED TO COMPLETE/FINISH THE SURGERY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678382 ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH

    Patients

    Seq Age Sex Outcome Treatment
    1