BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INO THERAPEUTICS

    MDR report key: 332592 · Received May 7, 2001

    Report

    Report Number
    332592
    Event Type
    Malfunction
    Date Received
    May 7, 2001
    Date of Event
    February 26, 2001
    Report Date
    May 7, 2001
    Manufacturer
    INO THERAPEUTICS
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    MACHINE INDICATED "SYSTEM FAILURE" AND "COMMUNICATIONS LOST". MFR CLAIMS THIS WAS OPERATOR ERRO AS THE SAME RESPIRATORY THERAPIST REPORTED ALL 3 FAILURES OF THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21104 INO THERAPEUTICS INOVENT TRANSPORT CBK INO THERAPEUTICS 6444 *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 DAY Other