BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 6292197 · Received February 1, 2017

    Report

    Report Number
    3007420694-2017-00022
    Event Type
    Malfunction
    Date Received
    February 1, 2017
    Report Date
    February 1, 2017
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. AB LTD (UNDER REGISTRATION #9617021). AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO SITE NO LONGER BEING A MANUFACTURER AND UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJO HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WERE SUBMITTED UNDER REGISTRATION #9611530 OR MEDIBO (MEDIBO MEDICAL PRODUCTS NV / 3004468271) AND AH MAGOG (ARJOHUNTLEIGH MAGOG INC. / 9681684). FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR TEMPO PASSIVE FLOOR LIFT WE HAVE FOUND A LOW NUMBER OF OTHER SIMILAR CASES - BATTERY DROP OUT OF THE DEVICE. NO TREND FOR THEM EXISTS. PLEASE NOTE THAT ARJOHUNTLEIGH MANUFACTURED OVER (B)(4) TEMPO PASSIVE FLOOR LIFTS. IF COMPARED TO THE NUMBER OF SOLD DEVICES AND IN COMPARISON TO THEIR DAILY USE THE OCCURRENCE RATE OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CONSIDERED TO BE VERY LOW. IT WAS REPORTED TO ARJOHUNTLEIGH THAT A BATTERY FELL OUT OF THE TEMPO PASSIVE FLOOR LIFT ONTO THE CAREGIVER. NO SERIOUS INJURY HAS BEEN SUSTAINED BY THE INVOLVED PERSON. IT WAS CONFIRMED THAT SHE WENT HOME AFTER THE INCIDENT AND WAS BACK TO WORK THE NEXT DAY. SHE HAD A SORE FOOT BUT WAS FINE. IT IS CONSIDERED THAT THE DEVICE WAS INVOLVED WITH A REPORTABLE INCIDENT AT THAT TIME - BATTERY DROP THAT COULD CAUSE USER'S INJURY. IN COURSE OF THE INVESTIGATION IT HAS BEEN TRIED TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE BATTERY WAS A CORRECT TYPE FOR THE LIFT. THE DEVICE WAS INSPECTED AFTER THE INCIDENT BY AN ARJOHUNTLEIGH REPRESENTATIVE. NO FAILURE WAS FOUND WITH IT, NOR WITH THE BATTERY ITSELF. THE LIFT WAS FUNCTIONING PROPERLY. THE BATTERY CONNECTION WAS FUNCTIONING PROPERLY AS WELL. IT CAN BE STATED THAT THE DEVICE MET ITS SPECIFICATION DURING THE CLAIMED EVENT. PLEASE NOTE THAT THIS TEMPO LIFT HAS ALREADY EXCEEDED ITS EXPECTED OPERATIONAL LIFE - 10 YEARS FROM THE DATE OF MANUFACTURE ACCORDING TO THE LABELING, FOR OVER 1.5 YEAR. WHAT IS MORE, THIS IS THE FIRST TIME WHEN THIS TYPE OF EVENT TOOK PLACE ON THAT DEVICE. THIS APPEARS TO POINT TO THE ISSUE NOT BEING SYSTEMIC OR DESIGN-RELATED. NO TRAINING RECORDS FOR THE FACILITY STAFF COULD BE PROVIDED. AS PER THE ARJOHUNTLEIGH REPRESENTATIVE INSPECTING THE LIFT AFTER THE INCIDENT IT IS MOST LIKELY THAT THE BATTERY FELL ON THE CAREGIVER'S FOOT WHEN SHE TRIED TO PLACE THE BATTERY IN THE HOLDER DUE TO MISUSE. SHE DID NOT LINE IT UP WITH THE CONNECTOR PINS PROPERLY ACCORDING TO THE PROVIDED INFORMATION. PLEASE NOTE THAT ACCORDING TO TEMPO OPERATING AND PRODUCT CARE INSTRUCTIONS (ISSUE 5): "BEFORE APPROACHING THE PATIENT: ENSURE THE BATTERY PACK SUPPLIED IS FULLY CHARGED BEFORE USE. WHEN THE BATTERY PACK IS FULLY CHARGED REMOVE IT FROM THE CHARGER UNIT AND INSERT INTO THE BATTERY POSITION OF THE TEMPO SITUATED AT THE REAR OF THE MAST BY FIRSTLY, LOCATING THE RECESS ACROSS THE BOTTOM OF THE BATTERY WITH THE PROTRUSION AT THE BOTTOM OF THE BATTERY POSITION, THEN PIVOT THE BATTERY INTO POSITION UNTIL THE RETAINING CATCH OPERATES. ELECTRICAL CONNECTION WILL BE MADE AUTOMATICALLY." FROM ABOVE FINDINGS IT IS CONCLUDED THAT THIS INCIDENT IS RELATED TO USE ERROR - NOT FOLLOWING THE INSTRUCTION FOR USE. THE RECEIVED INFORMATION AND OUR EVALUATION AS DESCRIBED ABOVE SHOW THAT IF TEMPO OPERATING AND PRODUCT CARE INSTRUCTIONS HAD BEEN FOLLOWED, THERE WOULD HAVE BEEN NO PATIENT OR CAREGIVER AT RISK. LOOKING AT THE INCIDENT SCENARIO IT HAS BEEN ESTABLISHED THAT TEMPO WAS INVOLVED WITH THE ADVERSE EVENT - BATTERY FELL OUT OF THE DEVICE. IT IS UNKNOWN WHETHER IT WAS BEING USED FOR PATIENT HANDLING AT THAT TIME. THERE WAS NO DEVICE DEFICIENCY FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE DROP AND FROM THAT PERSPECTIVE THE DEVICE WAS UP TO ITS SPECIFICATION AT THE TIME OF THE INCIDENT.

    Description of Event or Problem · 1

    ARJOHUNTLEIGH HAS BECOME AWARE OF THIS EVENT ON (B)(6) 2017 - AS REPORTED, A BATTERY FELL OUT OF THE TEMPO PASSIVE FLOOR LIFT ONTO THE CAREGIVER. NO SERIOUS INJURY HAS BEEN SUSTAINED BY THE INVOLVED PERSON. IT WAS CONFIRMED THAT SHE WENT HOME AFTER THE INCIDENT AND WAS BACK TO WORK THE NEXT DAY. SHE HAD A SORE FOOT BUT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76744 TEMPO NON-AC-POWERED PATIENT LIFT FSA ARJO MED. AB LTD. KPB50

    Patients

    Seq Age Sex Outcome Treatment
    1 Other