BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM ULTRASONICS INC., SYSTEM 83 PLUS 9

    MDR report key: 3061176 · Received April 10, 2013

    Report

    Report Number
    2523209-2013-00005
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    KOG
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013 THE CUSTOMER NOTICED INCORRECT TEMPERATURE READINGS ON THE SYSTEM PRINTOUT. THE BIOMED PERSONNEL FOUND THE RESERVOIR TEMPERATURE IN BAY 1 WAS 26C WHILE THE DISPLAYED READ 35C; THE RESERVOIR TEMPERATURE ON BY 2 READ 26C WHILE THE DISPLAY READ 36C. THE SYSTEM PRINTOUT READ 24C AND 35C. THE CUSTOMER CHECKED THEIR DATABASE AND FOUND THAT THIS SITUATION STARTED ON (B)(6) 2013. CUSTOMER ULTRASONICS DISPATCHED A SERVICE TECHNICIAN TO THE FACILITY ON (B)(6) 2013. THE SERVICE TECHNICIAN'S INVESTIGATION REVEALED THAT THE THERMOMETER USED BY THE FACILITY'S BIOMED PERSONNEL WAS INCORRECT. THE SERVICE TECHNICIAN READ THE RESERVOIR READINGS WITH A CALIBRATED THERMOMETER, THE READINGS WERE CORRECT IN THE RESERVOIR AND DID MATCH THE READINGS ON THE COMPUTER DISPLAY. THE DIFFERENCES IN THE SYSTEM'S PRINT OUT READINGS WAS ATTRIBUTED TO A BREAK IN THE WIRING OF THE 37 PIN CABLE CAUSED BY VIBRATION. THE SERVICE TECHNICIAN REPLACED THE CABLE AND THE MUX BOARD. THE SYSTEM WAS TESTED AND CONFIRMED TO BE WORKING PROPERLY. THE MUX BOARD AND CABLE WERE NOT RETURNED TO THE MANUFACTURER. THE CUSTOMER REPORTED THAT THERE WERE NO CONFIRMED PATIENT INJURIES AT THE TIME OF THIS REPORT. THE CUSTOMER STATED THAT THE SCOPES WERE PROPERLY PROCESSED ACCORDING TO THE FACILITY PROTOCOLS. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    INCORRECT DISPLAY OF TEMPERATURE READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149813 CUSTOM ULTRASONICS INC., SYSTEM 83 PLUS 9 MEDICAL WASHER-DISINFECTOR KOG CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS 9

    Patients

    Seq Age Sex Outcome Treatment
    1