BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H-2

    MDR report key: 284263 · Received June 23, 2000

    Report

    Report Number
    1221261-2000-00002
    Event Type
    Malfunction
    Date Received
    June 23, 2000
    Date of Event
    May 31, 2000
    Report Date
    June 20, 2000
    Manufacturer
    SIMS LEVEL 1, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SIMS LEVEL 1, INC. RECEIVED A REPORT FROM HOSP THAT DURING A SURGICAL PROCEDURE, WHEN PRESSURIZING FLUIDS TO 300MMHG, ABOUT 3/4 OF FRONT DOOR COVER OF H-2 CAME FLYING OFF. SIMS LEVEL 1, INC. IS WAITING FOR THE RETURN OF UNIT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-2 PRESSURE INFUSOR MEB SIMS LEVEL 1, INC. H-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other