BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAT 3000

    MDR report key: 1667723 · Received April 22, 2010

    Report

    Report Number
    2243057-2010-00001
    Event Type
    Malfunction
    Date Received
    April 22, 2010
    Date of Event
    March 23, 2010
    Report Date
    April 21, 2010
    Manufacturer
    PAUSCH LLC
    Product Code
    MMZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: A FOOT SWITCH ERROR F31 OCCURRING AND ALL TABLE MOTIONS WERE DISABLED. THE TABLE RESET DOES NOT CLEAR ERROR BECAUSE, THE MALFUNCTIONING FOOTSWITCH IS STILL ATTACHED TO THE SYSTEM AND THE SYSTEM WILL STILL SEE THAT IT IS STILL IN ERROR. A NEW FOOTSWITCH WAS SENT OUT AND THE SYSTEM WORKED AS INTENDED. THE SYSTEM PERFORMED AS DESIGNED, BECAUSE, IT DID NOT WORK IN THE VIOLATIVE STATE WHERE THE SYSTEM HAD DETECTED A MALFUNCTION THAT COULD AFFECT SAFETY. THE VIOLATIVE STATE BEING A FOOT SWITCH ERROR F31 OCCURRING. IF A FOOT PEDAL SWITCH (OR ANY OTHER SWITCH THAT CONTROL MOVEMENTS) IS NOT WORKING, THE SYSTEM IS TO DISABLE TABLE MOTIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE FOOT SWITCH WAS INOPERABLE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROMAT 3000 TABLE, CYSTOMETRIC, ELECTRIC MMZ PAUSCH LLC S 0116 0024

    Patients

    Seq Age Sex Outcome Treatment
    1 Other