BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEMISTIFIER

    MDR report key: 10042701 · Received May 11, 2020

    Report

    Report Number
    10042701
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    March 30, 2020
    Report Date
    April 1, 2020
    Manufacturer
    PEACE MEDICAL, INC.
    Product Code
    CBN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE DEMISTIFIER 2000 IS NOT UP TO THE TASK OF MOVING COVID-19 PATIENTS OVER LONG DISTANCES. IT IS TOP HEAVY AND HAS A TENDENCY TO TIP. THE CANOPY IS EASILY CAUGHT IN THE WHEELS AND TEARS OFF, THE BATTERY LASTED AT BEST 15 MINUTES AND DIED 3/4 OF THE WAY FROM THE ED TO 360 THUS WAS NOT ABLE TO PROVIDE NEGATIVE FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508485 DEMISTIFIER APPARATUS, GAS-SCAVENGING CBN PEACE MEDICAL, INC. 2000C

    Patients

    Seq Age Sex Outcome Treatment
    1 730 DA