BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE

    MDR report key: 6808550 · Received August 21, 2017

    Report

    Report Number
    0001954182-2017-00020
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    April 5, 2017
    Report Date
    August 21, 2017
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PK081047
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). PMA/510(K)#: K081047; K123188; K133786. THE DEVICE HISTORY RECORD (DHR) REVIEW FOR ULTRA DUO FLEX FLUID CART WAS UNABLE TO BE REVIEWED AS THE SERIAL NUMBER IS UNKNOWN. THE PREVIOUS REPAIR REPORT FOR ULTRA DUO FLEX FLUID CART WAS UNABLE TO BE REVIEWED AS THE SERIAL NUMBER IS UNKNOWN. THE REPORTED EVENT WAS CONFIRMED BY THE SERVICE TECHNICIAN WHO PERFORMED THE SERVICE. ON (B)(4) 2017, IT WAS REPORTED FROM (B)(6) HOSPITAL THAT A CART HAD A HOT SMELL. ON (B)(4) 2017, (B)(4) WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE ON (B)(4) 2017 AND CONFIRMED THAT THE CART HAD A BAD SMELL. THE TECHNICIAN DETERMINED THAT IT WAS NOT AN ELECTRICAL ISSUE, SOMETIMES GET AN ODOR FROM THE PAINT ON THE VACUUM PUMP WARMING UP EARLY IN A UNITS LIFE. THE TECHNICIAN REPORTED THAT NO REPAIRS WERE NEEDED. THE TECHNICIAN THEN VERIFIED THAT THE CART WAS FUNCTIONING AS INTENDED. THE TECHNICIAN THEN RETURNED THE CART TO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED AND INSPECTED. PER (B)(4), A REPAIR CHECKLIST IS NOT REQUIRED. SERVICE WORK ORDER (B)(4) ON (B)(4) 2017. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION. ADDITIONALLY, A SMELL IS SUBJECTIVE TO THE PERSON¿S SENSITIVITY AND PERSONAL APPRECIATION OF DIFFERENT ODORS. 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 WAS REPORTED THAT A UNIT HAD TO BE CHECKED OUT DUE TO A "HOT" SMELL. THE EVENT WAS NOTICED DURING SURGERY BUT THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587783 ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE FLUID CART JCX DORNOCH N/A

    Patients

    Seq Age Sex Outcome Treatment
    1