BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA 3000

    MDR report key: 1971730 · Received January 17, 2011

    Report

    Report Number
    3004468271-2011-00008
    Event Type
    Other
    Date Received
    January 17, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 28, 2010
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER (HOSPITAL (B)(6)) STATED THAT THE FACILITY PREFERS 2 STAFF MEMBERS TO BE INVOLVED IN PT TRANSFERS, AND THAT THEIR POLICY MAY CHANGE TO REFLECT THIS. DURING ARJOHUNTLEIGH QA'S CONVERSATION WITH THE FACILITY'S RISK MANAGER, THEY COMMUNICATED THAT IN THEIR VIEW OF THE INCIDENT, THERE WAS NO ALLEGATION OF PRODUCT DEFICIENCY, AND THAT THE PT WAS VIEWED AS CAUSING THE NEAR-FALL DUE TO HIS ACTIONS. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    MALE PT WITH SOME MOBILITY ISSUES, WHO COULD BEAR SOME WEIGHT WAS INVOLVED IN A BED TO TOILET TRANSFER (1 STAFF MEMBER WAS INVOLVED). THE PT BEGAN TO SLIDE OUT OF THE SLING, BUT THERE WAS ENOUGH TIME FOR THE CAREGIVER TO GO AROUND AND SIT ON THE TOILET SEAT TO BEAR THEIR WEIGHT (PT ENDED UP SITTING ON THE CAREGIVER), WHILE THEY CALLED FOR ASSISTANCE. THERE WAS NO INJURY REPORTED. F/U CONVERSATION WITH FACILITY RISK MGR ON (B)(6) 2010, REVEALED THAT THE PT WAS NOT COMFORTABLE WITH HIS ARMS ON THE OUTSIDE OF THE FRAME (WITH HIS HANDS ON THE OUTER GRASPING HANDLES), AND MOVED HIS ARMS INSIDE THE LIFT/SLING (TAKING HIS HANDS OFF THE OUTER GRASPING HANDLES). ARJOHUNTLEIGH QA INQUIRED IF A FULL ASSESSMENT WAS MADE OF THE PT PRIOR TO USING THE SARA 3000 FOR TRANSFER DUTIES AND THE RISK MGR RESPONDED THAT THIS WAS THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 ACTIVE FLOOR LIFT FSA MEDIBO MEDICAL PRODUCTS NV HEA1002-US

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other