BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA BED

    MDR report key: 2052415 · Received March 16, 2011

    Report

    Report Number
    1824206-2011-01602
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REPLACED THE SIDE RAIL ASSEMBLY TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.

    Description of Event or Problem · 1

    TECHNICIAN ALLEGED THAT THE SIDE RAIL ASSEMBLY IS BROKEN COMPLETELY OFF. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1600

    Patients

    Seq Age Sex Outcome Treatment
    1