BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXICAIR MC-3

    MDR report key: 466317 · Received June 12, 2003

    Report

    Report Number
    1045510-2003-00015
    Event Type
    Malfunction
    Date Received
    June 12, 2003
    Date of Event
    May 16, 2003
    Report Date
    June 12, 2003
    Manufacturer
    HILL-ROM MANUFACTURING, INC.
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SIDERAIL LATCH MALFUNCTION RESULTING IN PATIENT FALL. NO INJURY INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXICAIR MC-3 LOW AIR-LOSS THERAPY IOQ HILL-ROM MANUFACTURING, INC. M4000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other