BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAL WATER PLATFORM (CWP)

    MDR report key: 3688045 · Received March 19, 2014

    Report

    Report Number
    3019131-2014-00009
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    February 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K974899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE STATES THAT A SOLENOID VALVE FAILED. THIS RESULTED IN THE CWP EMITTING SMOKE FROM THE CABINET AND THE UNIT SHUT DOWN. THE CWP HAS BEEN REPAIRED BY USER PERSONNEL. MAR COR HAS REQUESTED ADDITIONAL INFORMATION TO DETERMINE WHICH SOLENOID VALVE HAD THE ISSUE. THERE WERE NO REPORTS OF FIRE - JUST SMOKE. THERE WERE NO REPORTS OF PATIENT INJURY AS A RESULT OF THE SMOKE AND/OR MACHINE SHUT DOWN. MAR COR WILL CONTINUE TO MONITOR THIS COMPLAINT WITHIN THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    VALVE HAS BEEN DETERMINED TO BE THE INLET WATER SOLENOID VALVE.

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING THAT THE NURSES GOT AN ALARM AND NO WATER. OBSERVED SMOKE COMING FROM THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162198 CENTRAL WATER PLATFORM (CWP) REEVERSE OSMOSIS SYSTEM FIP MAR COR PURIFICATION 101366 WA8MA

    Patients

    Seq Age Sex Outcome Treatment
    1