BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN MANUAL BEACH CHAIR

    MDR report key: 1395267 · Received March 11, 2009

    Report

    Report Number
    1221538-2009-00002
    Event Type
    Malfunction
    Date Received
    March 11, 2009
    Date of Event
    February 12, 2009
    Report Date
    March 11, 2009
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISASSEMBLY OF THE RETURNED CHAIR DEMONSTRATED THAT ONE OF THE SCREWS ATTACHED TO THE BACK OF THE UNIT WAS BROKEN. ONCE A WEIGHT/LOAD WAS PLACED IN THE CHAIR (SIMULATING A PT'S WEIGHT), THE BACK OF THE UNIT WAS NO LONGER ABLE TO HOLD POSITION AS INTENDED. ONCE THE SCREW WAS REPLACED AND THE CHAIR RE-ASSEMBLED, THE UNIT FUNCTIONED PROPERLY ONCE AGAIN.

    Description of Event or Problem · 1

    ON (B)(6)2009, AN ALLEN MEDICAL SALES REPRESENTATIVE WAS CONTACTED ABOUT AN ISSUE WITH THE ALLEN MANUAL BEACH CHAIR. THE BACK OF THE UNIT WAS NOT HOLDING POSITION PROPERLY WITH THE WEIGHT OF A PT IN IT. WITHOUT THE PT WEIGHT IN THE UNIT, THE DEVICE REPORTEDLY WAS WORKING FINE. THERE WERE NO INJURIES TO REPORT. THE FACILITY TOOK THE DEVICE OUT OF USE AND RETURNED IT TO US FOR EVAL AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MANUAL BEACH CHAIR SHOULDER CHAIR, MANUAL BEACH CHAIR FWZ ALLEN MEDICAL SYSTEMS O-SC-A3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention