BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2222917 · Received July 15, 2011

    Report

    Report Number
    1824206-2011-03751
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 25, 2011
    Manufacturer
    EMEA
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH REPLACED THE SIDE RAIL TO RESOLVE THIS PROBLEM.

    Description of Event or Problem · 1

    COMPLAINT ALLEGED THAT THE SIDERAIL WAS NOT LOCKING WHEN RAISED. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC-POWERED ADJUSTABLE HOSPITAL BED FNL EMEA P1840

    Patients

    Seq Age Sex Outcome Treatment
    1