BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUA SMART

    MDR report key: 18161257 · Received November 16, 2023

    Report

    Report Number
    MW5148261
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Report Date
    November 15, 2023
    Manufacturer
    MEDICA USA INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE MACHINE HAD FREQUENT AIR DETECTIONS. AFTER CHECKING FOR POWER BOARD FAILURE, THE HOSPITAL HAD TO BUY REPLACEMENT PARTS. NEW PARTS SN.(B)(6), BAD BOARD SN.(B)(6). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64855 EQUA SMART DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI MEDICA USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown