BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARA STEDY

    MDR report key: 3820115 · Received May 6, 2014

    Report

    Report Number
    9681684-2014-00028
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    INM
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS INITIALLY REVIEWED AND ASSESSED AS A NON-REPORTABLE COMPLAINT, BASED ON THE INITIAL EVALUATION PERFORMED. INVESTIGATION PERFORMED FOR A SUBSEQUENT SIMILAR EVENT REVEALED THIS COMPLAINT SHOULD HAVE BEEN REPORTED, THEREFORE IT IS BEING REPORTED RETROSPECTIVELY. ARJOHUNTLEIGH HAS RECEIVED A COMPLAINT WHERE THE PATIENT HAD A NEAR FALL AS THE CASTOR BRAKE UNLOCKED AND THE DEVICE SUDDENLY MOVED WHEN SHE WAS STANDING UP ON THE SARA STEDY. ARJOHUNTLEIGH REPRESENTATIVE PERFORMED AN ON-SITE VISIT AFTER THE INCIDENT. THE DEVICE WAS IN GOOD CONDITION EXCEPT THE CASTOR BRAKES. A COMPLETE INVESTIGATION WAS PERFORMED BY THE DESIGNATED COMPLAINTS HANDLING UNIT (DCHU), INCLUDING A REVIEW OF THE TREND OF SIMILAR PROBLEM, SIMILAR DEVICE AND HISTORY OF THE PRODUCT. IT WAS THE FIRST MDR RELATED TO A REAR CASTOR WITH BRAKES MALFUNCTION. NO MANUFACTURING ANOMALIES WERE FOUND WHEN REVIEWING THE DEVICE HISTORY RECORD OF THE PRODUCT. THE FAILURE OF THE BRAKE HAS BEEN IDENTIFIED TO OCCUR AT THE WHITE PLASTIC INSERT, WHICH IS LINKED TO THE ACTIVATION PEDAL. THE EXACT NATURE OF THE FAILURE HAS NOT BEEN DETERMINED. IT COULD BE RELATED TO THE DESIGN OF THE PART, ITS MANUFACTURING PROCESS OR AN ABUSIVE USE. SINCE IT IS UNKNOWN WHICH FACTOR CAUSED THE PLASTIC COMPONENT TO FAIL, THE CAUSE OF FAILURE COULD NOT BE DETERMINED. A CORRECTIVE ACTION WAS INITIATED TO IMPROVE THE DURABILITY OF THE REAR CASTORS WITH BRAKES. THE DEVICE FAILED TO MEET SPECIFICATIONS, WAS IN USE AT THE TIME OF THE EVENT AND CONTRIBUTED TO THE OUTCOME OF THE EVENT. SINCE THE DEFECTIVE PART HAS ALREADY BEEN REPLACED, THERE ARE NO FURTHER RECOMMENDATIONS. THE COMPLAINT HAS BEEN REPORTED TO THE COMPETENT AUTHORITIES IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271851 SARA STEDY INM ARJOHUNTLEIGH MAGOG INC.

    Patients

    Seq Age Sex Outcome Treatment
    1