BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2272038 · Received September 11, 2011

    Report

    Report Number
    2272038
    Event Type
    Malfunction
    Date Received
    September 11, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    NEMSCHOFF
    Product Code
    FKS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US

    Narratives

    Description of Event or Problem · 1

    THERE BECAME AN ISSUE WITH THE HEATERS ON THE CHAIRS NOT WORKING. THERE WAS A PAD BEING USED ON THE BACK OF THE CHAIR AND WHEN THAT WAS REMOVED THERE APPEARED TO BE A BURN MARK ON THE BACK OF THE CHAIR. AT THAT TIME THE DEPARTMENT WAS INSTRUCTED NOT TO USE ANY HEATERS ON THE CHAIRS UNTIL THE COMPANY WAS NOTIFIED AND THE CHAIRS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * RENAL DIALYSIS CHAIR FKS NEMSCHOFF 791-12 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *