BEUDAMED
    FDA Adverse Event Summary report: N

    EVEREST AND JENNINGS

    MDR report key: 3560382 · Received December 6, 2013

    Report

    Report Number
    2428983-2013-00002
    Date Received
    December 6, 2013
    Date of Event
    November 11, 2013
    Report Date
    December 6, 2013
    Manufacturer
    ZHONGSHAN A AND J MEDICAL EQUIPMENT CO, LTD
    Product Code
    IOR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PARAMOUNT XD WHEELCHAIR (650 POUND WEIGHT CAPACITY) USER MANUAL INSTRUCTIONS FOR OPENING WHEELCHAIR: WARNING: "DO NOT PLACE YOUR HAND BETWEEN SEAT TUBE AND SIDE PANEL."

    Description of Event or Problem · 1

    A UNION HOSPITAL REPRESENTATIVE REPORTED A VOLUNTEER WAS IN THE PROCESS OF ASSISTING A PATIENT INTO A WHEELCHAIR BY OPENING THE WHEELCHAIR. THE VOLUNTEER THOUGHT THE WHEELCHAIR WAS COMPLETELY OPEN AND LOCKED INTO POSITION. WHICH UNFORTUNATELY WAS NOT THE CASE. IN THE PROCESS OF THE PATIENT POSITIONING HIMSELF INTO THE CHAIR, HE PLACED HIS LEFT HAND BETWEEN THE SEAT RAIL AND FRAME INSTEAD OF ON THE ARM REST. AS THE PATIENT APPLIED HIS WEIGHT TO THE SEAT HIS LEFT MIDDLE FINGER WAS CAUGHT UNDERNEATH THE SEAT RESULTING IN A MIDDLE FINGER OPEN FRACTURE AND PARTIAL AMPUTATION ABOVE FIRST KNUCKLE. WOUND WAS CLOSED AND PATIENT WAS SENT TO AN ORTHOPEDIC SPECIALIST. THE FACILITY REPORTED THE WHEELCHAIR WAS TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634170 EVEREST AND JENNINGS PARAMOUNT XD MANUAL WHEELCHAIR IOR ZHONGSHAN A AND J MEDICAL EQUIPMENT CO, LTD 5PX10620

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention