BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA 3000

    MDR report key: 1748161 · Received December 16, 2009

    Report

    Report Number
    3004468271-2009-00048
    Event Type
    Other
    Date Received
    December 16, 2009
    Date of Event
    April 27, 2009
    Report Date
    April 29, 2009
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 THE SAME RESULT AS THE MDR REVIEW: THIS IS ESTABLISHED TO BE AN ISOLATED OCCURRENCE. A REVIEW OF SCRAP AND REWORK HISTORY WAS PERFORMED TO DETECT RELEVANT INFO; NO RELEVANT INFO WITH REGARDS TO THIS INCIDENT WAS FOUND. THE PRODUCT'S DHR WAS REVIEWED FOR ANOMALIES; NONE WERE FOUND. THE PRODUCT'S RECALL HISTORY WAS REVIEWED FOR LINKS WITH THE INCIDENT DESCRIPTION; NO RECALLS HAVE BEEN CARRIED OUT ON ANY ACTIVE LIFT DEVICE TO DATE. THE RELEVANT PRODUCT INVOLVED IN THE COMPLAINT WAS NOT REQUESTED TO BE RETURNED. PICTURES WERE RECEIVED OF THE DEFICIENCY AND IN COMBINATION WITH PREVIOUS SIMULATION, OFFER SUFFICIENT INSIGHT INTO THE PROBLEM FOR THIS INVESTIGATION. A REVIEW OF THE INTENDED LIFETIME OF THE PRODUCT WAS PERFORMED. THE DEVICE INVOLVED IS 4 YEARS OLD AND FALLS WELL WITHIN THE 10 YEAR EXPECTED LIFETIME. CONCLUSION: WE HAVE BEEN ABLE TO DUPLICATE THE FAILURE MODE OF THIS COMPLAINT. WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS NO COMPLAINT TREND WITH THIS PRODUCT AND ISSUE. WE HAVE BEEN ABLE TO FIND NO CONTRIBUTING MANUFACTURING ANOMALIES. THE ROOT CAUSE OF THE INCIDENT WAS FOUND TO BE USE ERROR, NOT MAKING ALLOWANCES FOR OBSTRUCTIONS: THE HANDGRIP DAMAGE CORRESPONDS TO DAMAGE CAUSED BY MULTIPLE CASES OF THE HANDGRIP BEING RAISED UNDER AN OBSTACLE. THE DEVICE OPI CLEARLY WARNS: TO DAILY CHECK FOR THIS TYPE OF DAMAGE; TO MAKE ALLOWANCES FOR OBSTRUCTIONS. CORRECTIVE ACTIONS: FROM THIS INFO, MEDIBO CAN NOT COME TO A CORRECTIVE ACTION TOWARD THE PRODUCT. MEDIBO STRONGLY RECOMMENDS REVIEW OF THE TRAINING METHODS, AND ENDORSES RETRAINING OF STAFF TO THE OPI. ALSO, MEDIBO WILL CONTINUE TRENDING OF THIS AS YET ISOLATED OCCURRENCE, FOR POSSIBLE FUTURE ACTIONS.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THAT WHILE PREPARING FOR A TRANSFER WITH THE SARA 3000, A CAREGIVER HAD BENT DOWN TO THE SIDE OF THE HOIST, HITTING HER HEAD IN DOING SO. IT IS REPORTED THE SARA 3000 IN QUESTION HAD DAMAGED (B)(4) HAND GRIPS, EXPOSING THE METAL UNDER THE HAND GRIPS. INITIALLY, AN EYE INJURY WAS REPORTED. FURTHER CONTACT WITH THE CUSTOMER REVEALED THAT THE INJURY APPEARS TO BE A SKIN LACERATION IN THE VICINITY OF THE EYE. (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. HEA0002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other