BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC POSITIONING CHAIR

    MDR report key: 2060936 · Received January 20, 2011

    Report

    Report Number
    1834066-2011-00002
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    November 4, 2010
    Report Date
    January 20, 2011
    Manufacturer
    CHAMPION MANUFACTURING
    Product Code
    INO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED A MEDWATCH REPORT (B)(4). SMOKE WAS OBSERVED AFTER REPOSITIONING A RECLINER CHAIR. MFR IS WORKING TO OBTAIN PRODUCT INVOLVED IN THE ALLEGED INCIDENT. PRODUCT HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME, SO IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, LACK OF MAINTENANCE, OR A DEVICE MODIFICATION MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON SMOKE OBSERVED.

    Description of Event or Problem · 1

    THE MEDWATCH REPORT ALLEGES THE RECLINING CHAIR WAS SMOKING AFTER THE CONSUMER REPOSITIONED THE CHAIR. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRIC POSITIONING CHAIR 890.3110 INO CHAMPION MANUFACTURING NONE PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1