BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTROL UNIT, DYONICS 25

    MDR report key: 2970152 · Received February 20, 2013

    Report

    Report Number
    1643264-2013-00003
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SMITH & NEPHEW INC. OKLAHOMA CITY MANUFACTURING
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP FAILED FUNCTIONAL TESTING. PUMP'S PRESSURE AND FLOW BECAME VERY ERRATIC DURING WET TEST. ROOT CAUSE OF ERRATIC BEHAVIOR IS DEFECTIVE TRANSDUCERS P1 AND P2 PN: (B)(4). BOTH TRANSDUCERS HAVE DATE CODES OF 0208 (WEEK:2 YEAR:2008) WHICH CLASSIFY THEM AS OLD STYLE AND WERE REPLACED WITH AN IMPROVED TRANSDUCER PN: (B)(4). THE CUT IN DATE FOR THE NEW TYPE TRANSDUCER WAS 06/13/2010. SEE CAR# 125. (B)(4).

    Description of Event or Problem · 1

    DYONICS 25 CONTROL UNIT BEGAN TO PUMP OUT OF CONTROL RESULTING IN THE STAFF HAVING TO STOP IT. THE SHOULDER HAD TO BE OPENED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73796 CONTROL UNIT, DYONICS 25 CONTROL UNIT, DYONICS 25 HRX SMITH & NEPHEW INC. OKLAHOMA CITY MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1