BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARA 3000

    MDR report key: 2713627 · Received August 17, 2012

    Report

    Report Number
    3004468271-2012-00036
    Event Type
    Malfunction
    Date Received
    August 17, 2012
    Date of Event
    July 7, 2012
    Report Date
    July 25, 2012
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MFR MEDIBO MEDICAL PRODUCTS (B)(4). THERE IS NO TREND OBSERVED FOR LIFT UNCONTROLLED MOVEMENT IN REPORTABLE COMPLAINTS ON SARA 3000. THE NUMBER OF COMPLAINTS WHERE IT WAS INDICATED THAT UNCOMMANDED MOVEMENT OF SARA 3000 AFFECTED ON PT APPEARS TO BE RELATIVELY LIMITED. IN ACCORDANCE TO MFG DATES THERE IS NO INDICATIONS THAT THE FAILURES ARE MFG ISSUES. THE SARA 3000 SERIAL NO (B)(4) WAS MANUFACTURED IN MEDIBO, IN (B)(4) 2007. ROOT CAUSE ANALYSIS: SARA 3000 FAILED TO OPERATE DURING TREATMENT (TOILETING) OF PT ACCORDING TO CUSTOMER'S DESCRIPTION. IT WAS REPORTED, THAT PT WAS PARTIALLY LIFTED, WHEN THE LIFT RAISED WITHOUT COMMAND TO FULLY RAISED POSITION. WHEN HANDSET WAS COMMANDED DOWN, LEGS OPENED, LIFT WOULD NOT LOWER. THE PT WAS THEN UNHOOKED FROM THE SLING/LIFT AND MANUALLY LOWERED ONTO TOILET. PLEASE NOTE: EMERGENCY LOWERING FUNCTION (SYSTEM FAILURE LOWER OVERRIDE) HAVE NOT BEEN USED. THERE ARE NO INDICATIONS, THAT THE SYSTEM FAILURE LOWER OVERRIDE FAILED TO OPERATE. NO INJURY OCCURRED. DEVICE WAS NOT RETURNED TO MFR. IT WAS EVALUATED BY ARJOHUNTLEIGH TECH AT CUSTOMER PREMISES. FULFILLED INCIDENT DESCRIPTION FORM AND PICTURES OF THE LIFT WERE PROVIDED. DEVICE APPEARS IN GOOD CONDITION. THE HANDGRIPS WERE DAMAGED ON THE ENDS FROM CONTACT WITH FOREIGN OBJECT (WHICH IS NOT A SAFETY ISSUE AND IS NOT A SUBJECT OF THIS INVESTIGATION). THE FAILURE COULD NOT BE DUPLICATED AT THE TIME OF VISIT, BECAUSE THE HANDSET WAS REPLACED BEFORE SERVICE CALL WAS PLACED. THE CUSTOMER STATED THAT THE HANDSET CORD WAS DAMAGED, AND CONCLUDED THE HANDSET WAS THE CAUSE OF THE LIFT MANIPULATION. I WAS UNABLE TO VERIFY OR DUPLICATE ANY UNCONTROLLED MOVEMENT OR MALFUNCTION AT THE TIME OF THE INSPECTION. CUSTOMER WAS UNABLE TO LOCATE THE ORIGINAL DAMAGED HANDSET AT THE TIME OF THE INSPECTION. WE ARE NOT ABLE TO CONFIRM THE PROBLEM WITH HANDSET WITHOUT EVAL OF THIS PART. PROBLEM WITH HANDSET WAS NOT CONFIRMED BY SERVICE, IN THE IDF THERE IS A STATEMENT, THAT ¿CUSTOMER WAS UNABLE TO LOCATE THE ORIGINAL DAMAGED HANDSET¿ OPERATING AND PRODUCT CARE INSTRUCTIONS CLEARLY DESCRIBES, THAT IF THE HANDSET OR DUAL CONTROL FEATURE FAILS TO OPERATE "THE SYSTEM FAILURE LOWER OVERRIDE" SHOULD BE USED TO SAFELY LOWER THE PT. FINAL CONCLUSIONS: WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES, BECAUSE THERE WAS A POTENTIAL OF PT HARM DUE TO USE ERROR. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MFG ANOMALIES. WE HAVE FOUND THE LIFT WAS BEING USED FOR PT HANDLING AT THE TIME OF THE EVENT. THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE A USER ERROR.

    Description of Event or Problem · 1

    ACCORDING TO CUSTOMER DESCRIPTION: TOILETING RESIDENT, HAD RESIDENT PARTIALLY LIFTED, THE LIFT RAISED WITHOUT COMMAND TO FULLY RAISED POSITION. CNA CALLED FOR HELP. WHEN HANDSET WAS COMMANDED DOWN, LEGS OPENED, LIFT WOULD NOT LOWER. THE RESIDENT WAS THEN UNHOOKED FROM THE SLING/LIFT AND MANUALLY LOWERED ONTO TOILET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 ACTIVE FLOOR LIFTS FSA MEDIBO N.V. HEA0002-US

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other