BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SVCE REPL,CONTROL UNIT, DYONICS 25

    MDR report key: 3901380 · Received June 30, 2014

    Report

    Report Number
    1643264-2014-00012
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    OKLAHOMA CITY MANUFACTURING SITE
    Product Code
    HRX
    PMA / PMN Number
    K051326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE SVCE REPL, CONTROL UNIT, DYONICS 25 WAS RETURNED FOR EVALUATION. THE REPORTED COMPLAINT OF "NOT RECOGNIZING HANDPIECE" COULD NOT BE REPRODUCED. THE PRODUCT PASSED FUNCTIONAL TESTING WITH NO ERRATIC PRESSURE/FLOW PROBLEMS OR ALARMS. THE DEVICE PASSED FUNCTIONAL TESTING DURING 48 HOUR BURN-IN ON WET STATION UTILIZING LOW AND HIGH PRESSURE AND FLOW SETTINGS. RAW AND ZERO TRANSDUCER READINGS NORMAL AND WELL WITHIN SPECS DURING ALL TESTS. NO PROBLEM FOUND. (B)(4).

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE UTILIZING A SVCE REPL, CONTROL UNIT, DYONICS 25, IT WAS REPORTED THAT THE PUMP FAILED TO RECOGNIZE HANDPIECE. THE PRESSURE WAS SET TO 20, BUT CONTINUED TO INCREASE TO OVER 50. THERE WAS NO BACK-UP DEVICE AVAILABLE; THEREFORE, THE PROCEDURE WAS ABORTED. THERE WERE NO REPORTS OF PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380544 SVCE REPL,CONTROL UNIT, DYONICS 25 SVCE REPL,CONTROL UNIT, DYONICS 25 HRX OKLAHOMA CITY MANUFACTURING SITE 7211010S

    Patients

    Seq Age Sex Outcome Treatment
    1