BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA 3000

    MDR report key: 1748139 · Received December 16, 2009

    Report

    Report Number
    3004468271-2009-00047
    Event Type
    Other
    Date Received
    December 16, 2009
    Date of Event
    April 24, 2009
    Report Date
    May 22, 2009
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN MDR REVIEW WAS PERFORMED FOR THIS AND SIMILAR RELEVANT PRODUCTS; THERE HAVE BEEN NO PREVIOUS MDR'S RELATING TO THIS FAILURE MODE, TO DATE. A REVIEW OF RELATED COMPLAINTS FOR THIS AND SIMILAR RELEVANT PRODUCTS WAS PERFORMED WITH GENERALLY THE SAME RESULT AS THE MDR REVIEW: THERE WAS ONE PREVIOUS OCCASION WHERE THE CAREGIVER WAS NOT CAREFUL AND STANDING AT THE SIDE OF THE DEVICE, BENT OVER AND HIT HER HEAD AGAINST IT WITHOUT SERIOUS INJURY. THIS CURRENT EVENT IS ESTABLISHED TO BE AN ISOLATED OCCURRENCE. A REVIEW OF SCRAP AND REWORK HISTORY WAS PERFORMED TO DETECT RELEVANT INFO; NONE WAS FOUND. THE PRODUCT'S DHR WAS REVIEWED FOR ANOMALIES; NONE WERE FOUND. THE DEVICE WAS PRODUCED AND TESTED IN 12/2003. THE DESIGN IS LARGELY THE SAME AS IT IS TODAY. THE PRODUCT'S RECALL HISTORY WAS REVIEWED FOR LINKS WITH THE INCIDENT DESCRIPTION; NO RECALLS HAVE BEEN CARRIED OUT ON THIS TYPE OF LIFT. THE RELEVANT PRODUCT INVOLVED IN THE COMPLAINT WAS NOT REQUESTED TO BE RETURNED. INFO ON THE PRODUCT AND ITS MAINTENANCE WERE RECEIVED AND OFFER SUFFICIENT INSIGHT INTO THE PROBLEM FOR THIS INVESTIGATION. A REVIEW OF THE INTENDED LIFETIME OF THE PRODUCT WAS PERFORMED. THE DEVICE INVOLVED IS 6 YEARS OLD AND FALLS WITHIN THE EXPECTED 10 YEAR LIFETIME. A RISK ANALYSIS REVIEW WAS MADE. THE RA OF THE SARA 3000 DOES NOT STATE THE FAILURE MODE AT HAND, AND THEREFORE, THE INFO GAINED FROM THIS REPORT WAS FORWARDED TO THE R&D TEAM FOR EVALUATION OF FUTURE ADAPTATION INTO THE RA. CONCLUSION: WE HAVE NOT BEEN ABLE TO DUPLICATE THE FAILURE MODE OF THIS COMPLAINT: PT HURTING HIS HEAD WHILE BEING TRANSFERRED WITH SARA 3000. WE HAVE BEEN ABLE TO ESTABLISH THAT THIS IS AN ISOLATED OCCURRENCE. WE HAVE NOT BEEN ABLE TO FIND CONTRIBUTING MANUFACTURING ANOMALIES. FROM THIS INFO, WE CANNOT COME TO DECIDE WITH ANY DEGREE OF CERTAINTY, ON A ROOT CAUSE OF THE EVENT. HOWEVER, IT HAS BEEN ESTABLISHED THAT WHEN FOLLOWING THE LABELING (OPI) OF THE DEVICE, THERE IS SUFFICIENT CLEARANCE AROUND THE HEAD OF THE PERSON BEING TRANSFERRED, SO THAT TURNING THE HEAD WILL NOT CAUSE ANY RISK OF INJURY: IT WAS FOUND THAT SINCE DURING THE INTENDED USE, NO SUCH RISK CAN OCCUR. THEREFORE, THE EVENT APPEARS TO HAVE COME FROM A USE ERROR. CORRECTIVE ACTIONS: SINCE THE ROOT CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED, NO CORRECTIVE ACTION CAN BE DIRECTLY ATTRIBUTED TO ADDRESS IT. HOWEVER, MEDIBO STRONGLY SUGGESTS A RETRAINING OF THE OPERATORS OF THE DEVICE AT THE FACILITY AGAINST THE CURRENT LABELING OF THE DEVICE. (OPI) MEDIBO WILL CONTINUE TRENDING OF THIS FAILURE MODE WITH THE DEVICE FOR POSSIBLE FUTURE ACTIONS.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THAT DURING A TRANSFER FROM BED TO WHEELCHAIR, THE PERSON ON THE LIFT TURNED HER HEAD AND HIT THE LEFT EYE ON THE LIFT. IT IS REPORTED, THE PERSON HURT HER EYELID. ALTHOUGH EFFORTS WERE MADE TO ESTABLISH THE NATURE OF THE INJURY, NO FURTHER INFO HAS COME TO SURFACE, APART FROM THE INDICATION THAT THE PERSON WAS FINE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 LIFT, PATIENT, NON-AC-POWERED FSA MEDIBO N.V. HEA0001

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other