BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CWP

    MDR report key: 3869772 · Received June 12, 2014

    Report

    Report Number
    3019131-2014-00022
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K974899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE STATES THE INLET SOLENOID VALVE (PART OF THE REVERSE OSMOSIS CWP) FAILED. THE VALVE EMITTED SMOKE AND THE FIRE DEPT WAS CALLED. THE INLET VALVE WAS BYPASSED AND PATIENT TREATMENT WAS RESSUMED. PATIENT TREATMENT WAS DELAYED 1 HOUR AND 15 MINUTES. NO PATIENT OR HANDLER INJURIES OR ILLNESS WERE REPORTED. MAR COR PURIFICATION WILL CONTINUE TO MONITOR THIS COMPLAINT WITHIN THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    VALVE FAILED TO OPERATE AND THE CWP RO UNIT SHUT DOWN. THERE WAS A DELAY IN PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348213 CWP REVERSE OSMOSIS SYSTEM FIP MAR COR PURIFICATION 101366

    Patients

    Seq Age Sex Outcome Treatment
    1