BEUDAMED
    FDA Adverse Event Death Summary report: N

    MECHANICAL CHAIR/TRANSPORT CHAIR

    MDR report key: 2615472 · Received June 14, 2012

    Report

    Report Number
    1834066-2012-00007
    Event Type
    Death
    Date Received
    June 14, 2012
    Date of Event
    November 5, 2009
    Report Date
    June 13, 2012
    Manufacturer
    CHAMPION MANUFACTURING
    Product Code
    KMN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(6) 2012. (B)(6) 2012 - (B)(6) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL, SERIAL NUMBER/DATE CODE AND AGE OF PRODUCT ARE UNKNOWN AT THIS TIME. THE PATIENT IS A FEMALE WHOSE AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE PATIENTS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE PATIENTS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE PATIENT WAS ALLEGEDLY SEATED IN A CHAMPION MANUFACTURING RECLINER, WHEN SHE ATTEMPTED TO STAND UP, AFTER A TREATMENT AT A DIALYSIS CENTER, THE ARM ON THE RECLINER ALLEGEDLY SWUNG OPEN. THE PATIENT ALLEGEDLY FELL AND SUSTAINED UNSPECIFIED FRACTURES AND SUBSEQUENTLY PASSED AWAY. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    ATTORNEY INVOLVEMENT ALLEGED WHEN PATIENT ATTEMPTED TO STAND AFTER TREATMENT WHEN THE ARM OF THE CHAIR SWUNG OPEN. SERIOUS INJURY ALLEGED AND RESULTED IN DEATH.

    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