BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA 3000

    MDR report key: 1880417 · Received September 29, 2010

    Report

    Report Number
    3004468271-2010-00029
    Event Type
    Other
    Date Received
    September 29, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 30, 2010
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN AS TO WHY THE PATIENT TOOK THEIR HANDS OFF OF THE HANDLES DURING THE TRANSFER. FURTHER INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AT 6:40 PM, GETTING READY TO PUT RESIDENT TO BED. RESIDENT WAS RAISED UP ON THE SARA IN GOOD POSITION. WAS ABOUT TO MOVE THE LIFT TOWARDS THE BED AND RESIDENT TOOK BOTH HANDS OFF THE HANDLES AND HER BUTTOCKS LOWERED SLIGHTLY WHILE STILL REMAINING IN THE LIFT. THE STAFF MEMBER WORKING ON HER OWN QUICKLY PLACED THE RESIDENT OVER HER WHEELCHAIR AND LOWERED THE RESIDENT ON TO THE CHAIR. IT WAS THEN THE STAFF NOTICED A TEAR ON HER HAND AND CALLED THE NURSE TO HAVE A LOOK. THE RESIDENT DID NOT FALL NOR DID SHE HIT HER HEAD. CAREGIVER'S DESCRIPTION OF OCCURRENCE; THE RESIDENT'S HAND WAS TREATED WITH A HAND DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 ACTIVE FLOOR LIFTS FSA MEDIBO MEDICAL PRODUCTS NV HEA0002-US

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other