BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIO C2 WHEELCHAIR

    MDR report key: 5273524 · Received November 10, 2015

    Report

    Report Number
    3011134213-2015-00001
    Event Type
    Malfunction
    Date Received
    November 10, 2015
    Date of Event
    October 11, 2015
    Report Date
    October 14, 2015
    Manufacturer
    MOTION COMPOSITES INC.
    Product Code
    IOR
    PMA / PMN Number
    K120628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION THAT THE MALFUNCTION COULD LEAD TO SERIOUS INJURY IF IT WERE TO RECUR IS BASED ON THE FACT THAT ANOTHER CONTRIBUTING FACTOR WAS INVOLVED IN THE EVENT (DEVICE USE THAT DOES NOT FOLLOW INDUSTRY STANDARDS). THE MOTION COMPOSITES USER MANUALS ARE DEFICIENT IN REGARDS TO WARNINGS FOR THE USE OF PUSH HANDLES. BASED ON INDUSTRY STANDARDS, PUSH HANDLES SHOULD NEVER BE USED TO LIFT THE DEVICE, ESPECIALLY WHEN IT IS OCCUPIED. WARNINGS WILL BE ADDED IN THE MOTION COMPOSITES USER MANUALS TO CLEARLY STATE THESE INSTRUCTIONS. (B)(4).

    Description of Event or Problem · 1

    THE EVENT TOOK PLACE IN (B)(6) WHERE THE USER RESIDES. PUSH HANDLES LOCATED AT THE TOP OF THE BACKREST BROKE OFF WHILE THE WHEELCHAIR WITH THE OCCUPANT SITTING IN IT WAS BEING TRANSPORTED DOWN A SET OF STAIRS. THE SITUATION WAS DESCRIBED AS FOLLOWS: ONE PERSON HOLDING A PUSH HANDLE ON EACH SIDE OF THE CHAIR, ONE PERSON IN THE FRONT OF THE CHAIR HOLDING THE FRAME AND FRONT WHEELS (CASTER). WHILE DESCENDING THE OUTDOOR FRONT STEPS OF THE HOME (4 OR 5 STEPS), BOTH PUSH HANDLES BROKE. THE BREAK IS LOCATED JUST BEFORE THE CURVE OF THE PUSH HANDLE WHERE THERE IS A SCREW TO SECURE THE BACK UPHOLSTERY (SEE PICTURES IN ATTACHMENT 1). WHEN THE PUSH HANDLES BROKE, THE WHEELCHAIR AND ITS OCCUPANT LEANED BACKWARDS. ONE OF THE PERSONS ASSISTING THE USER MANAGED TO RESTRAIN THE BACKWARD MOVEMENT WHILE THE BACK PACK INSTALLED ON THE WHEELCHAIR MINIMIZED THE IMPACT. THE OCCUPANT DID NOT SUFFER ANY IMMEDIATE OR SUBSEQUENT INJURY. THIS WHEELCHAIR WAS MANUFACTURED ON FEBRUARY 5TH 2015 WITH PUSH HANDLES CODE 32507 VERSION B.2. PICTURES OF THE BROKEN HANDLES WERE SENT TO THE CUSTOMER SERVICE ON (B)(6) 2015 AND THE DEVICE AND BROKEN HANDLES WERE RETURNED TO THE MANUFACTURING SITE ON 10/28/2015. INSPECTION OF THE BROKEN HANDLES AND RETURNED DEVICE SHOW THAT ONE OF THE HANDLES HAD A LOCALIZED TUBE THICKNESS UNDER MANUFACTURING TOLERANCE. ALSO, BOTH HANDLE GRIPS SHOW SIGNS OF WEAR ON THE UNDERSIDE PORTION, INDICATING A PREVIOUS IMPACT OF AN UNDETERMINED FORCE. IT IS SUSPECTED THAT THE HANDLE WITH THE TUBE THICKNESS UNDER TOLERANCE BROKE FIRST AND THAT THE SECOND HANDLE BROKE AFTER ALL OF THE USER WEIGHT WAS TRANSFERRED ON IT. THE RUPTURE PATTERNS CONFIRM THIS HYPOTHESIS. THE WHEELCHAIR DID NOT SUFFER ANY OTHER DAMAGE DURING THE EVENT. THE PUSH HANDLES FOR WHEELCHAIR #23622 WERE REPLACED AND THE DEVICE WAS SHIPPED FROM THE MANUFACTURING SITE ON 10/29/2015. IT IS TO BE NOTED THAT SPECIFIC ACTIONS HAVE ALREADY BEEN TAKEN FOR PUSH HANDLES CODE 32507 IN APRIL 2015. AN INVESTIGATION INITIATED IN FEBRUARY 2015 (REGARDING IMPROVEMENT OF ANOTHER TYPE OF WHEELCHAIR HANDLE) CONCLUDED THAT THERE WAS A POTENTIAL ISSUE WITH THE MANUFACTURING OF HANDLES CODE 32507 VERSION B.2 RESULTING IN A PORTION OF THE HANDLE TUBE BEING THINNER THAN THE REST, CREATING A WEAKNESS. TESTS CONCLUDED THAT ABOUT 0.15 PERCENT OF PUSH HANDLES WERE IMPACTED BY THIS DEFECT. THE ISSUE WAS ADDRESSED WITH THE SUPPLIER AND A 100 PERCENT VERIFICATION OF ALL PUSH HANDLES CODE 32507 WAS IMPLEMENTED AT THE TIME TO ASSURE THE SUPPLIER ACTIONS WERE EFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746353 HELIO C2 WHEELCHAIR MECHANICAL WHEELCHAIR IOR MOTION COMPOSITES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR