BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-LEG

    MDR report key: 6597312 · Received May 30, 2017

    Report

    Report Number
    9615892-2017-00016
    Event Type
    Injury
    Date Received
    May 30, 2017
    Date of Event
    March 1, 2017
    Report Date
    May 30, 2017
    Manufacturer
    OTTO BOCK HEALTHCARE PRODUCTS GMBH
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE KNEE JOINT SHOWED A DEFECT OF THE VALVE BLOCK OF THE HYDRAULIC UNIT (CORRESPONDING ERROR CODE EMERGED AT LEAST 17 TIMES). THIS FAILURE IS RELIABLE RECOGNIZED BY THE SYSTEM AND LEADS TO AN ACTIVATION OF THE SAFETY MODE. THE REPETITIVE WARNING SIGNALS AND SAFETY MODES OF THE DEVICE (WHICH POINT OUT THAT THE DEVICE SHOULD BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION) WERE IGNORED BY THE USER (87 SELFTEST FAILURES AND AT LEAST 17 POSITIONING FAILURES WITH SAFETY MODES ACTIVATED BETWEEN 12/2016 AND 04/2017 ACCORDING TO PRODUCT STATUS REPORT). ACCORDING TO IFU THE DEVICE SHOULD HAVE BEEN RETURNED EARLIER FOR INSPECTION PURPOSES. SEE INSTRUCTION FOR USE (USER) - C-LEG 3C98-3/3C88-3 (646D790-04-1503), ISSUED ON MAR. 05, 2015: SECTION 9.3: SAFETY MODE THE PRODUCT AUTOMATICALLY SWITCHES TO SAFETY MODE IF A CRITICAL SYSTEM FAULT OCCURS (E.G. FAILURE OF A SENSOR SIGNAL). SAFETY MODE REMAINS IN EFFECT UNTIL THE ERROR HAS BEEN RECTIFIED. DEFAULT DAMPING VALUES ARE ACTIVATED IN SAFETY MODE. THIS MAKES LIMITED WALKING POSSIBLE FOR THE USER EVEN THOUGH THE SYSTEM IS NOT ACTIVE. THE SWITCH TO SAFETY MODE IS INDICATED BY BEEPS AND VIBRATION SIGNALS IMMEDIATELY PRIOR TO SWITCHING (SEE PAGE 66). SAFETY MODE CAN BE DISABLED BY CONNECTING THEN DISCONNECTING THE BATTERY CHARGER. IF THE PRODUCT SWITCHES INTO SAFETY MODE AGAIN, THIS MEANS A PERMANENT ERROR EXISTS. THE PRODUCT MUST BE INSPECTED BY AN AUTHORISED OTTOBOCK SERVICE CENTRE.

    Description of Event or Problem · 1

    INITIAL INFORMATION: KNEE IS VIBRATING AND BEEPING AND UNEXPECTEDLY LOCKING UP. WON'T HOLD A CHARGE, TRIED 3 DIFFERENT CHARGERS. FURTHER INFORMATION RECEIVED ON 05/29/2017: PT. WAS WALKING DOWN HOUSE STAIRS AND TALKING. PT. BRUISED FACE AND BROKE RIB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378621 C-LEG EXTERNAL ABOVE KNEE PROSTHESIS ISY OTTO BOCK HEALTHCARE PRODUCTS GMBH 3C98-3=9.2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other