BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE OSMOSIS SYSTEM

    MDR report key: 3666884 · Received March 7, 2014

    Report

    Report Number
    3019131-2014-00008
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 6, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K974899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE STATES THAT THE INLET SOLENOID VALVE (PART OF THE REVERSE OSMOSIS CWP) FAILED. THE CWP WAS EMITTING SMOKE FROM THE CABINET AND SHUT DOWN. MAR COR SERVICE ENGINEER WAS SENT TO THE SITE AND HE REPLACED THE VALVE. IN HIS REPORT, THE CAUSE OF THE INLET SOLENOID VALVE FAILURE MAY HAVE BEEN DUE TO THE LEAK IN THE UPPER HALF OF THE VALVE, ISSUES WITH THE O-RING ON THE VALVE, THE VALVE HAVING NO SHIELD, OR JUST A BAD COIL. THERE WAS NO REPORTS OF FIRE, JUST SMOKE. THE SMOKE WAS CONFINED TO THE WATER ROOM ONLY OF THE CLINIC. THERE WERE 7 PATIENTS THAT WERE DELAYED TREATMENT DUE TO THIS EVENT. NO PATIENTS OR HANDLERS WERE INJURED AS A RESULT OF THE SMOKE AND/OR MACHINE FAILURE. MAR COR PURIFICATION WILL CONTINUE TO MONITOR THIS COMPLAINT WITHIN THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    INLET SOLENOID COIL (PART OF THE REVERSE OSMOSIS CENTRAL WATER PLATFORM) FAILED CAUSING THE MACHINE TO EMIT SMOKE AND SHUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140866 REVERSE OSMOSIS SYSTEM CENTRAL WATER TREATMENT SYSTEM FIP MAR COR PURIFICATION 101366

    Patients

    Seq Age Sex Outcome Treatment
    1