BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERIWATER DIALYSIS RO+ SYSTEM

    MDR report key: 388231 · Received March 29, 2002

    Report

    Report Number
    1530185-2002-00001
    Event Type
    Malfunction
    Date Received
    March 29, 2002
    Date of Event
    October 2, 1998
    Report Date
    October 2, 1998
    Manufacturer
    AMERIWATER
    Product Code
    FIP
    Removal / Correction Number
    Z-0982-1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FUSE HOLDERS ON AMERIWATER MRO SYSTEM (CONTROLLER) WERE NOT RATED FOR CONTINUOUS DUTY. MRO SYSTEMS USED CONTINUOUSLY FOR 12 OR MORE HOURS BEGAN TO EXPERIENCE FUSE HOLDER FAILURES. THE SYMPTOMS INCLUDED: FUSE HOLDERS BECAME HOT TO THE POINT WHERE LABELING ON THE CONTROLLER MAY MELT GIVING OFF AN ODOR. THE LINE CORD MAY ALSO BECOME HOT AS A RESULT OF THE FUSE HOLDER. CONTINUAL FUSE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERIWATER DIALYSIS RO+ SYSTEM CLASS II MEDICAL DEVICE FOR REVERSE OSMOSIS FIP AMERIWATER MRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other