BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTELLE CCDS CRITICAL CARE DECONTAMINATION SYSTEM

    MDR report key: 10505208 · Received September 8, 2020

    Report

    Report Number
    1523658-2020-00002
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Report Date
    September 4, 2020
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QLA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A BACKUP BIOQUELL UNIT WAS USED THE (B)(4) SITE. THE BACKUP UNIT RAN WITH AN INCORRECT PROCESS SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965241 BATTELLE CCDS CRITICAL CARE DECONTAMINATION SYSTEM DECONTAMINATION SYSTEM QLA BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1