BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROSTAR RS 0100

    MDR report key: 86385 · Received April 24, 1997

    Report

    Report Number
    MW1011200
    Event Type
    Malfunction
    Date Received
    April 24, 1997
    Date of Event
    March 27, 1997
    Report Date
    April 15, 1997
    Manufacturer
    STACKHOUSE, INC.
    Product Code
    LGM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PENTAMIDINE TREATMENT, METAL SHAVINGS CAUSED BY FAILURE OF THE MOTORIZED PULLEY ESCAPED FROM THE INTERIOR OF THE CART. NO APPARENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROSTAR RS 0100 ENVIRONMENTAL CHAMBER LGM STACKHOUSE, INC. RS 0100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other