BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3071969 · Received April 22, 2013

    Report

    Report Number
    3003433498-2013-00190
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH TWO DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE IHCS9FX CARROLL HEALTHCARE BED FOOT DECK AND THE RATCHET WERE FOUND BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172980 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL CARROLL HEALTHCARE IHCS9FX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other