BEUDAMED
    FDA Adverse Event Death Summary report: N

    MECHANICAL CHAIR/TRANSPORT CHAIR

    MDR report key: 2569127 · Received May 10, 2012

    Report

    Report Number
    1834066-2012-00002
    Event Type
    Death
    Date Received
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    CHAMPION MANUFACTURING
    Product Code
    KMN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL AND SERIAL NUMBER/DATE CODE ARE 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 CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. INVACARE CALLED ATTORNEY REPRESENTING THE MEDICAL CENTER ON (B)(6) 2012. HE DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE SPECIFIC DEVICE (MODEL, SERIAL #) OR THE REPORTED MALFUNCTION. A LETTER WAS SENT THE SAME DAY DOCUMENTING A REQUEST FOR ADDITIONAL DETAIL. FOLLOW UP INFORMATION WILL BE SUBMITTED WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    LETTER FROM LEGAL REP ALLEGED FOOTREST ON CHAMPION RECLINER MALFUNCTIONED. DEATH ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL CHAIR/TRANSPORT CHAIR 890.3100 KMN CHAMPION MANUFACTURING UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death