BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOKOMAT SYSTEM

    MDR report key: 1450062 · Received May 29, 2009

    Report

    Report Number
    3003781275-2009-00001
    Event Type
    Malfunction
    Date Received
    May 29, 2009
    Date of Event
    May 19, 2009
    Report Date
    May 29, 2009
    Manufacturer
    HOCOMA AG
    Product Code
    BXB
    Removal / Correction Number
    3003781275-5/27/09-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    4. NO PT, USER OR THIRD PERSONS WERE INJURED. INTERNAL TESTS AT (B)(6) ON (B)(6) 2009, HAVE INDICATED THAT THE COMBINED USE OF SOME OLDER SOFTWARE VERSIONS AND THE CURRENT SOFTWARE (B)(4) WITH THE SAME DATABASE LEAD TO A CHANGE OF THE SOFTWARE SETTING "SENSITIVITY". (B)(4) OTHER VERSIONS DEDUCED FROM SOFTWARE SPECIFICATIONS). THE "SENSITIVITY" SETTING INFLUENCES THE LIMITS USED FOR THE CONTROL METHODS STOP THE SYSTEM IF THE DEVIATION OF CURRENT TO ACTUAL POSITION OR THE FORCES APPLIED BY THE DEVICE ARE HIGHER THAN SAID LIMIT. THESE CONTROL METHODS CONTRIBUTE TO THE REDUCTION OF THE RISK OF APPLYING HIGH FORCES TO THE PTS' LEGS IN CASE OF STUMBLING OR BLOCKING OF THE LEG AGAINST ANY OBSTACLES WHICH MIGHT LEAD TO FRACTURES OF THE LOWER EXTREMITY. A SENSITIVITY VALUE OF 2.0 IS THE DEFAULT AND CORRESPONDS TO THE LOWEST LIMITS (LESS FORCES APPLIED). THE VALUE CAN BE SET BY THE THERAPIST INDIVIDUALLY FOR THE PT IN THE RANGE OF 1.0-2.0 IN STEPS OF 0.1 IF TRAINING OF THE PT IS NOT POSSIBLE BECAUSE OF HIGH SPASTICITY, I.E. INCREASED MUSCLE TONE, OR HIGHER BODY WEIGHT. THE CHANGE OF THE "SENSITIVITY" VALUE OCCURS AT THE TIME WHEN THE PT'S DATA IS ACCESSED IN ONE OF THE OLDER VERSION AS LISTED ABOVE AFTER THEY WERE ACCESSED BY A CURRENT VERSION AS LISTED ABOVE. THE VALUE IS ALWAYS CHANGED TO 1.0 (HIGHER FORCE LIMITS). THE VALUE CHANGE AFFECTS THE OLDER AND THE CURRENT VERSIONS UNLESS THE VALUE IS CORRECTED MANUALLY. THE EFFECT ONLY AFFECTS DATA OF PTS TRAINING USING THE PEDIATRIC MODULE. THE PROBLEM CAN NOT OCCUR IF ONLY EITHER THE CURRENT OR THE OLDER VERSIONS ARE USED. IMMEDIATE CORRECTIVE ACTIONS: INFO TO THE CUSTOMERS USING THE ATTACHED FIELD SAFETY NOTICE THAT INSTRUCTS THE USERS, ENSURE THAT ONLY ONE SOFTWARE VERSION IS INSTALLED AND USED (AND POSSIBLY TO DEINSTALL ALL OLDER VERSIONS) AND TO CHECK THE SENSITIVITY SETTING AT THE BEGINNING OF EACH TRAINING WITH PEDIATRIC MODULE. FURTHER CORRECTIVE ACTIONS: MODIFICATION AND RELEASE OF A SOFTWARE UPGRADE THAT PREVENTS THE SOFTWARE INCOMPATIBILITY BY USING AN ALTERNATIVE STORAGE METHOD, SETTING THE (SAFEST) SENSITIVITY VALUE OF 2.0 WHEN STARTING ANY TRAINING WITH THE PEDIATRIC MODULE AND ALWAYS SAVING THE (SAFEST) SENSITIVITY VALUE OF 2.0 INTO THE PERMANENT STORAGE. THIS UPGRADE WILL DETECT SITUATIONS IN WHICH THE PERMANENT STORAGE IS ALREADY AFFECTED AND SET THE STORED VALUE TO THE SAFEST SETTING 2.0. THIS SOFTWARE UPGRADE WILL MAKE THE SECOND CORRECTIVE SUPERFLUOUS.

    Description of Event or Problem · 1

    ONE (B)(6) CUSTOMER REPORTED ON (B)(6) 2009, THAT A SOFTWARE SETTING DID CHANGE WITHOUT USER ACTION. THIS SOFTWARE SETTING AFFECTS THE PARAMETERS OF ONE CONTROL MECHANISM IMPLEMENTED IN THE SOFTWARE. THE PARAMETER IS SHOWN ON THE USER MONITOR AND COULD BE CORRECTED MANUALLY. NO PTS, THERAPISTS OR THIRD PERSONS HAVE BEEN AFFECTED OR INJURED. NO DAMAGES TO THE DEVICE HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOKOMAT SYSTEM BXB HOCOMA AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA