BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL CHAIR & TABLE

    MDR report key: 2506679 · Received March 28, 2012

    Report

    Report Number
    1834066-2012-00001
    Event Type
    Injury
    Date Received
    March 28, 2012
    Date of Event
    January 31, 2011
    Report Date
    March 27, 2012
    Manufacturer
    CHAMPION MANUFACTURING
    Product Code
    INO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. CHAMPION MODEL 141064, SERIAL NUMBER/DATE CODE IS UNKNOWN. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. INVACARE CALLED TO SPEAK WITH CHAMPION AS THEY CONDUCT AN INVESTIGATION AS WELL. CHAMPION STATED THAT THE FOOTREST WAS ALLEGEDLY RELEASED UNEXPECTEDLY WHICH CAUSED THE FOOTREST TO STRIKE THE NURSE'S FINGER AND BREAK IT. THE FACILITY, (B)(6) HOSPITAL, DOES NOT FEEL THAT THE CHAIR MALFUNCTIONED IN ANY WAY. THE INCIDENT WAS REPORTED BECAUSE THE FACILITY CONTACTED CHAMPION TO SEE IF ADDITIONAL TRAINING COULD BE DONE TO PREVENT THIS FROM HAPPENING AGAIN. THE PRODUCT IS NOT BEING RETURNED. THE PRODUCT DID NOT MALFUNCTION.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE PATIENT RELEASED THE FOOT REST UNEXPECTEDLY. SERIOUS INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL CHAIR & TABLE 880.6140 INO CHAMPION MANUFACTURING 141064

    Patients

    Seq Age Sex Outcome Treatment
    1 Other