BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA 3000

    MDR report key: 2396655 · Received January 3, 2012

    Report

    Report Number
    3004468271-2011-00015
    Event Type
    Other
    Date Received
    January 3, 2012
    Date of Event
    February 18, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY BELIEVED HEART ATTACK HAPPENED DURING TRANSFER. (B)(4) HAS BEEN NOTIFIED THAT AN OFFICIAL AUTOPSY HAS NOT YET BEEN RELEASED AT THE TIME OF THIS SUBMISSION. (B)(4) HAS BEEN MADE AWARE THAT THE INITIAL REPORTER NO LONGER WORKS AT THE FACILITY. CURRENT CONTACT THAT ALL F/U IS BEING SUBMITTED TO IS (B)(4). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE FACILITY'S REPORT, AS TOLD TO THE (B)(4) SERVICE TECH DURING AN ON-SITE INVESTIGATION: "CAREGIVER WAS TRANSFERRING PT FROM A WHEELCHAIR TO THE BED. HE HAD A BOWEL MOVEMENT DURING TRANSPORTATION. CAREGIVER TRIED TO CHANGE PT WHILE HE WAS FASTENED TO THE LIFT. ALL OF A SUDDEN HE GAVE IN AS IF HE FAINTED AND THE CAREGIVER TRIED TO CATCH HIM AND INJURED HER BACK. [(B)(4) SERVICE TECH] WAS TOLD THAT THE LEG STRAP OF THE LIFT WASN'T FASTENED TO THE PT." FACILITY ALSO REPORTS THAT THE PT FELL STRAIGHT DOWN DUE TO THEIR LEGS NOT BEING STRAPPED, BUT DID NOT HIT THE FLOOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other