BEUDAMED
    FDA Adverse Event Summary report: N

    CAVIWAVE DUAL CHAMBER CONSOLE

    MDR report key: 3061897 · Received April 16, 2013

    Report

    Report Number
    3003950207-2013-00002
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STERIS CORPORATION - DISTRIBUTION CENTER
    Product Code
    FLG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE TECHNICIAN INSPECTED THE UNIT, AND FOUND A LOOSE HOSE CONNECTION AT THE FACILITY'S INCOMING HOT WATER LINE, AND LEAKS AT THE DI WATER PIPING AND CONSOLE DRAIN PIPING. THE TECHNICIAN REPAIRED ALL LEAKS, TESTED THE UNIT, FOUND IT OPERATIONAL AND RETURNED IT TO SERVICE. THE UNIT WAS INSTALLED IN (B)(6) 2011, AND IS NOT UNDER STERIS SERVICE CONTRACT. THE CAVIWAVE SONIC WASHER OPERATOR AND MAINTENANCE MANUAL STATES (PG. 4-4) "INSPECT UNIT FOR EVIDENCE OF LEAKS. HAVE QUALIFIED SERVICE TECHNICIAN TIGHTEN PLUMBING AS NEEDED". THIS IS TO BE EXECUTED ON A MONTHLY BASIS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE CAVIWAVE WASHER WAS LEAKING WATER, DAMAGING CEILING TILES IN THE ROOM BELOW. NO INJURIES WERE REPORTED. NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163957 CAVIWAVE DUAL CHAMBER CONSOLE CLEANER FLG STERIS CORPORATION - DISTRIBUTION CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1