BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYONICS 25 CONTROL UNIT

    MDR report key: 3821969 · Received May 20, 2014

    Report

    Report Number
    1643264-2014-00006
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 4, 2014
    Manufacturer
    OKLAHOMA CITY MANUFACTURING SITE
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT OF PUMP FAILURE COULD NOT BE REPRODUCED. PRODUCT PASSED FUNCTIONAL TESTING PER PROCESS SUMMARY WITH NO ERRATIC PRESSURE OR FLOW PROBLEMS. PRODUCT PASSED FUNCTIONAL TESTING DURING 48 HOUR BURN-IN ON WET STATION UTILIZING LOW AND HIGH PRESSURE AND FLOW SETTINGS. RAW AND ZERO TRANSDUCER READINGS WERE NORMAL AND WELL WITHIN SPECIFICATIONS DURING ALL TESTS. NO PROBLEM FOUND.(B)(4).

    Description of Event or Problem · 1

    DURING ARTHROSCOPY PROCEDURE IT WAS REPORTED THAT THE PUMP WAS NOT WORKING PROPERLY AND JOINT WAS DISTENDED. THE SURGEON IS A VERY EXPERIENCED USER WITH OF THE DYONICS PUMPS. FURTHER INFORMATION RECEIVED INDICATES THE SURGEON STATES ON (B)(6) 2014 THAT THE PATIENT STATUS IS FINE. HOWEVER IT IS UNKNOWN WHAT THE PATIENT STATUS WAS ON THE ACTUAL DAY OF THE PROCEDURE AND WHETHER OR NOT THE DISTENDED JOINT SUBSIDED DURING NORMAL RECOVERY PERIOD. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300191 DYONICS 25 CONTROL UNIT SVCE REPL,CONTROL UNIT, DYONICS 25 HRX OKLAHOMA CITY MANUFACTURING SITE 7211010S

    Patients

    Seq Age Sex Outcome Treatment
    1