BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS BED 9153650455

    MDR report key: 4881323 · Received July 1, 2015

    Report

    Report Number
    3003433498-2015-00100
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Report Date
    June 3, 2015
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE WELD ON FOOT/THIGH SECTION OF THE FRAME BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424602 CS BED 9153650455 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL CARROLL HEALTHCARE IHCS7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other