BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAL WATER PLATFORM

    MDR report key: 3793894 · Received May 6, 2014

    Report

    Report Number
    3019131-2014-00018
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K974899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 AND IT WAS REPORTED AS CATCHING ON FIRE. MAR COR SERVICE ENGINEER WAS SENT TO THE SITE AND HE REPLACED THE VALVE. AFTER CLOSE EVALUATION OF THE INLET SOLENOID VALVE, THERE WAS NO EVIDENCE OF FIRE OR SMOKE RESIDUE ON THE VALVE. PATIENTS THAT WERE DELAYED TREATMENT DUE TO THIS EVENT. NO PATIENTS OR HANDLERS WERE INJURED AS A RESULT OF THE MACHINE MALFUNCTION. MAR COR PURIFICATION WILL CONTINUE TO MONITOR THIS COMPLAINT WITHIN THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    INLET SOLENOID VALVE MALFUNCTIONED WITHIN THE MAR COR PURIFICATION REVERSE OSMOSIS WATER TREATMENT SYSTEM. THERE WAS DELAY IN PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270522 CENTRAL WATER PLATFORM REVERSE OSMOSIS SYSTEM FIP MAR COR PURIFICATION 103256

    Patients

    Seq Age Sex Outcome Treatment
    1