BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA 3000

    MDR report key: 2910023 · Received November 12, 2012

    Report

    Report Number
    3007420694-2012-00052
    Event Type
    Other
    Date Received
    November 12, 2012
    Date of Event
    October 14, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE MEDIBO MEDICAL PRODUCTS (B)(4). AS OF (B)(4) 2012, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MFR. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH (B)(4) AND ANY MEDWATCH REPORTS WILL BE SUBMITTED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE FOUND SOME CASES WITH SIMILAR FAULT DESCRIPTION (SLIP IN/FROM SLING), MAINLY RELATED TO USE ERROR. THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE ON SARA 3000 IS CONSIDERED TO BE LOW AND STABLE. WE FOUND NO DEFICIENCY WITH THE DEVICE. ADD'L INFO REC'D DURING THE INVESTIGATION WAS THAT THE CUSTOMER STATED THAT IT WAS NOT AN "INCIDENT" THAT CAUSED ANY CONCERN WITH THE SARA 3000, THE LIFT AND SLING WERE NOT TAKEN OUT OF SERVICE AND CONTINUED TO BE USED. A NUMBER OF USE ERRORS APPEAR TO HAVE CAUSED THE EVENT, THE MOST RELEVANT USE ERROR BEING A FAILURE TO EVALUATE THE PERSON TO BE TRANSFERRED BEFORE USE (PT WAS COMPLAINING ABOUT BACK PAIN DUE TO ARTHRITIS AND REACTED ADVERSELY TO BEING LIFTED AS A RESULT). NEED FOR THE PROFESSIONAL CLINICAL ASSESSMENT PRIOR TO USE OF SARA 3000 LIFT DEVICE IS STATED IN THE INSTRUCTION FOR USE (KKX81010M-EN ISSUE 2): 'WARNING: BEFORE ATTEMPTING TO RAISE A RESIDENT, A FULL CLINICAL ASSESSMENT OF THE RESIDENT'S CONDITION AND SUITABILITY MUST BE CARRIED OUT BY A QUALIFIED PERSON ON THE INDIVIDUAL RESIDENT TO DETERMINE IF IT IS ADVISABLE THAT HE OR SHE WILL BE LIFTED USING A SARA 3000 STANDING AND RAISING AID.' AS A REMINDER OF THE CONTENTS OF THE IFU THAT STATES THAT THE DEVICE OPERATOR MUST BE KNOWLEDGEABLE, WE RECOMMEND THAT THE FACILITY WILL ALWAYS TRAIN ITS STAFF AGAINST THE USE OF THE PRODUCTS BEFORE THE FIRST USE.

    Description of Event or Problem · 1

    ACCORDING TO THE MFR'S REP: "PT BEING TRANSFERRED FROM WHEELCHAIR TO RECLINER AND LET GO OF HAND GRIPS AND SLID DOWN SLING INTO RECLINER." IT WAS DESCRIBED TO AHUS QA THAT THE RESIDENT WAS COMPLAINING OF PAIN IN HER ARTHRITIC BACK AND RAISED HER ARMS WHILE ATTEMPTING TO SIT. THERE ARE 2 SERIAL NUMBERS LISTED BECAUSE THE FACILITY DID NOT SEGREGATE THE DEVICE AND SLING USED, SO BOTH UNITS ON-SITE WERE CHECKED (ALONG WITH THE SLINGS). ADDITIONALLY, THE RESIDENT PASSED AWAY DUE TO PNEUMONIA RECENTLY; X-RAYS WERE TAKEN AND WERE NEGATIVE, SO THIS INSTANCE WAS NOT RELATED TO HER EXPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 ACTIVE FLOOR LIFTS FSA ARJOHUNTLEIGH POLSKA SP. Z O.O. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other