BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS 25 CONTROL UNIT

    MDR report key: 1190737 · Received October 6, 2008

    Report

    Report Number
    1643264-2008-00020
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 9, 2008
    Manufacturer
    SMITH & NEPHEW INC.-ENDOSCOPY DIVISION
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WOULD NOT POWER UP CORRECTLY. FOUND ENGINE CARD NOT FULLY SEATED IN SOCKET ON ADAPTOR BOARD CAUSING BLANK SCREEN AND NO POWER. RESEATED ENGINE CARD AND PUMP POWERED UP CORRECTLY. UNABLE TO DETERMINE WHY CARD BECAME UNSEATED.

    Description of Event or Problem · 1

    BEFORE ARTHROSCOPIC ROTATOR CUFF REPAIR, NOTHING APPEARED ON THE FRONT PANEL WHEN THE UNIT WAS POWERED ON. IRRIGATION WAS CHANGED TO GRAVITY FEED, PATIENTS SHOULDER SWELLED DUE TO DELAY IN THE CASE. UNKNOWN DELAY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS 25 CONTROL UNIT DYONICS 25 HRX SMITH & NEPHEW INC.-ENDOSCOPY DIVISION 7211010

    Patients

    Seq Age Sex Outcome Treatment
    1