BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO

    MDR report key: 7756337 · Received August 7, 2018

    Report

    Report Number
    3007420694-2018-00156
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    July 10, 2018
    Report Date
    August 7, 2018
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). 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 THE 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. ON 13 JUL 2018, ARJO RECEIVED INFORMATION ABOUT AN EVENT INVOLVING TEMPO PASSIVE FLOOR LIFT WHICH OCCURRED AT (B)(6) LOCATED IN THE (B)(6), USA. FOLLOWING INFORMATION REPORTED BY THE CUSTOMER, WHILE THE CAREGIVER WAS RAISING THE RESIDENT, THE DEVICE LIFTING ARM SUDDENLY DROPPED AND HIT THE CAREGIVER'S HEAD. AS A CONSEQUENCE OF THE EVENT, THE CAREGIVER EXPERIENCED HEADACHES, DIZZINESS, AND VOMITING. SHE WAS TAKEN TO THE HOSPITAL FOR EXAMINATION. THE DIAGNOSIS SHOWED THAT THE CAREGIVER SUSTAINED THE CONCUSSION. AFTER THE EVENT, THE DEVICE WAS INSPECTED BY ARJO SERVICE TECHNICIAN. THE FUNCTIONAL TEST SHOWED THAT THE LIFT WAS WORKING PROPERLY, NO MALFUNCTION WAS DETECTED. THE SERVICE TECHNICIAN WAS NOT ABLE TO RE-CREATE THE REPORTED MALFUNCTION. ALL DEVICES ARE PROVIDED WITH THE INSTRUCTION FOR USE WHICH CLEARLY STATES HOW TO USE THE DEVICE., THE IFU FOR TEMPO (KPX 50550) CONTAINS INFORMATION THAT: "THE EXPECTED OPERATIONAL LIFE OF THE ARJO LIFT IS 10 (TEN) YEARS FROM THE DATE OF MANUFACTURE PROVIDING THAT THE FOLLOWING CONDITIONS ARE ADHERED TO: THE UNIT IS REGULARLY CARED FOR AND SERVICED IN ACCORDANCE WITH RECOMMENDED, THE UNIT IS MAINTAINED TO THE MINIMUM REQUIREMENTS AS PUBLISHED IN THE "PREVENTIVE MAINTENANCE SCHEDULE". THE SERVICING AND PRODUCT CARE, IN ACCORDANCE WITH ARJO REQUIREMENTS, MUST BEGIN WITH THE CUSTOMER'S FIRST USE OF THE UNIT. THE EQUIPMENT IS USED FOR ITS INTENDED PURPOSE ONLY AND IS OPERATED WITHIN THE PUBLISHED LIMITATIONS. ONLY ARJO DESIGNATED SPARE PARTS SHOULD BE USED." MOREOVER, IT NEEDS TO BE EMPHASIZED, THE DEVICE WAS IN USE FOR OVER 14 YEARS, THE DEVICE EXAMINATION SHOWED THAT THE LIFT HAD SIGNS OF WEAR AND TEAR. DURING AN INSPECTION OF THE INVOLVED DEVICE PERFORMED BY ARJO REPRESENTATIVE, THERE WAS NO FAILURE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED LIFTING ARM FALL. SUM UP, WHILE THE INCIDENT OCCURRED THE DEVICE WAS BEING USED FOR THE PATIENT'S TRANSFER. THE ROOT CAUSE WAS IMPOSSIBLE TO DEFINE DESPITE THE ANALYSIS OF ALL COLLECTED INFORMATION. AS PER ALLEGATION REPORTED THE LIFTING ARM LOWERED UNINTENTIONALLY, THE LIFT WAS NOT UP TO MANUFACTURER'S SPECIFICATION. THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO THE FACT THAT SERIOUS INJURY OCCURRED AS AN OUTCOME OF THE EVENT.

    Description of Event or Problem · 0

    ON 13 JUL 2018, ARJO RECEIVED INFORMATION ABOUT AN EVENT INVOLVING TEMPO PASSIVE FLOOR LIFT WHICH OCCURRED AT (B)(6), USA. FOLLOWING INFORMATION REPORTED BY THE CUSTOMER, WHILE THE CAREGIVER WAS RAISING THE RESIDENT, THE DEVICE LIFTING ARM SUDDENLY DROPPED AND HIT THE CAREGIVER'S HEAD. AS A CONSEQUENCE OF THE EVENT, THE CAREGIVER EXPERIENCED HEADACHES, DIZZINESS, AND VOMITING. SHE WAS TAKEN TO THE HOSPITAL FOR EXAMINATION. THE DIAGNOSIS SHOWED THAT THE CAREGIVER SUSTAINED THE CONCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597806 TEMPO LIFT, PATIENT, NON-AC-POWERED FSA ARJO MED. AB LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention