BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2882750 · Received December 20, 2012

    Report

    Report Number
    3003433498-2012-00115
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    December 19, 2012
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED THAT OCCURRED AT A CANADIAN LONG TERM CARE USER FACILITY. IT WAS LEARNED BY THE DEALER THAT THE T CABLE ONLY WORKS WHEN IT IS WIGGLED TO GET IT TO WORK. THE PART WAS REPLACED UNDER WARRANTY. NO INJURY TO THE INVOLVED END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL CARROLL HEALTHCARE IHCS7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other