BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 4262262 · Received November 6, 2014

    Report

    Report Number
    9681684-2014-00083
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. AB LTD (UNDER REGISTRATION #(B)(4)). AS OF (B)(4) 2010, THAT NUMBER WAS DEACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH (B)(4) AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #9681684. THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER ARJOHUNTLEIGH (B)(4) INC. (REGISTRATION #(B)(4)) ON BEHALF OF THE IMPORTER (B)(4). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. WHEN REVIEWING SIMILAR EVENTS FOR TEMPO PASSIVE LIFT, WE HAVEN'T FOUND ANY OTHER SIMILAR CASES WHERE DEVICE TIPPED DURING USE BECAUSE FAILURE OF CENTERING UNIT. PLEASE NOTE THAT ARJOHUNTLEIGH MANUFACTURED ABOUT (B)(4) TEMPO LIFTS TO DATE. THERE IS NO COMPLAINT TREND FOR THESE KIND OF EVENTS. THE DEVICE WAS INSPECTED BY AN ARJOHUNTLEIGH REPRESENTATIVE AT THE CUSTOMER SITE AND FOUND TO BE OUT OF THE SPECIFICATION. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. FROM RECEIVED INFORMATION BRUISES ON CAREGIVER'S SHOULDER OCCURRED AS A RESULT OF THIS INCIDENT. IN ACCORDANCE TO THE INVESTIGATION SO FAR, THE LABELLING EXCERPTS IN THE BELOW TEXT OF THIS SECTION, AND TO INFORMATION PROVIDED IN COMPLAINT (B)(6), THE MOST LIKELY ROOT CAUSE OF THIS EVENT APPEARS TO BE A COMBINATION OF: USER ERROR - USER NOT FOLLOWING RECOMMENDATION INCLUDING INSTRUCTION FOR USE; WORN OUT EQUIPMENT - DEVICE EXCEEDED ITS INTENDED LIFETIME. PLEASE SEE OUR EVALUATION BELOW REGARDING INCIDENT DESCRIBED IN COMPLAINT (B)(6). THE CENTERING UNIT (SPL5001) HOLD THE ACTUATOR IN PLACE, AND IT IS SECURED TO THE CHASSIS BY SCREWS (SPL1004). WHEN THE ACTUATOR OPENS OR CLOSE, BOTH LEGS WOULD MOVE AT THE SAME TIME, IN SYMMETRICAL MANNER. IF THE ACTUATOR WAS NOT HELD IN THE MIDDLE, IT WOULD MEAN THAT IT COULD NOT MOVE FROM RIGHT TO LEFT WHEN THE LEGS ARE NOT FULLY OPENED. ALSO, WHEN THE USER WOULD OPEN OR CLOSE THE LEG, IT IS MOST LIKELY THAT THE LEGS WILL NOT OPEN IN A SYMMETRICAL MANNER, BUT THAT ONE LEG WILL OPEN AND THEN THE OTHER. THERE ARE 2 SCENARIOS THAT CAN HAPPEN WHEN THE FAILURE OCCUR: IF THE CENTRALIZATION UNIT IS BROKEN, THE LEGS CAN MOVE SIDEWAYS WITHOUT INPUT FROM THE USER, IF THE LEGS ARE NOT FULLY OPENED OR FULLY CLOSE; IF THE CENTRALIZATION UNIT IS BROKEN, THE LEGS REMAIN IN THEIR NORMAL RANGE, SO THE LEFT REMAINS STABLE (BOTH LEGS ARE CLOSED). USER ERROR RECEIVED INFORMATION SHOWED THAT: LIFT IS IN GOOD CONDITION (EXCEPT BROKEN CHASSIS - DID NOT MEET IS SPECIFICATION); PATIENT WAS (B)(6).; TRANSFER TO BED. IMP REF#. (B)(4).

    Description of Event or Problem · 1

    INITIALLY IT WAS REPORTED BY ARJOHUNTLEIGH REPRESENTATIVE THAT THE LIFT TIPPED DURING USE. USER WAS TRANSFERRING THE PATIENT FROM WHEELCHAIR TO BED. WITH THE PATIENT IN UP POSITION AND LEGS WERE NOT OPEN ALL OF THE WAY, CAREGIVER PULLED LIFT TOWARDS BED AND IT FELL OVER ON TO HER. HITTING HER IN THE BACK OF HEAD AND RIGHT SHOULDER. THE CAREGIVER WENT TO ER AND IS FINE. CT SCAN AND X-RAY WERE NEGATIVE. THE CAREGIVER WAS AT WORK THE NEXT DAY. NO TIME OFF WAS NEEDED. FROM RECEIVED INFORMATION BRUISES ON CAREGIVER'S SHOULDER OCCURRED AS A RESULT OF THIS INCIDENT. DEVICE EXAMINATION INCLUDED IN INCIDENT DESCRIPTION FORM (IDF) AND FUNCTION TEST SHOWED THAT LEG ACTUATOR CENTER STRAP UNIT SCREWS BROKEN OFF AT THE HEADS. ARJOHUNTLEIGH REPRESENTATIVE WAS ABLE TO RE-CREATE DESCRIBED EVENT: "IF LEGS ARE NOT OPEN ALL THE WAY, THE LEGS CAN SWAY AND CAUSE LIFT NOT TO BE CENTERED AND STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713600 TEMPO FSA ARJO MED AB LTD KPA5010

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other