BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE

    MDR report key: 1665111 · Received April 15, 2010

    Report

    Report Number
    2937137-2010-00005
    Event Type
    Malfunction
    Date Received
    April 15, 2010
    Date of Event
    March 5, 2010
    Report Date
    April 12, 2010
    Manufacturer
    SUNRISE MEDICAL, INC.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAMPS WERE THE ONLY PARTS OF THE ASSEMBLY THAT WERE RETURNED TO THE MFR FOR EVAL AT THIS TIME. THE ACTUAL FOOTREST ASSEMBLY OR HARDWARE WAS NOT RETURNED. MANUFACTURE IS NOT ABLE TO DETERMINE A CONCLUSION WITHOUT REMAINING PARTS OF ASSEMBLY.

    Description of Event or Problem · 1

    REPORTER STATED THAT WHILE GOING THROUGH A DOORWAY AT A HOSPITAL THE FOOTREST FELL OUT AND CAUGHT THE DOOR JAM CAUSING HER TO FLIP FORWARD OUT OF THE CHAIR. USER WAS TAKEN TO THE ER DEPARTMENT. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKIE WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL, INC. QUICKIE GT EIR3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK