BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 2427513 · Received January 9, 2012

    Report

    Report Number
    3004468271-2012-00004
    Event Type
    Injury
    Date Received
    January 9, 2012
    Date of Event
    December 10, 2011
    Report Date
    December 12, 2011
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2010033 BY ARJOHUNTLEIGH (REGISTRATION#1419652) ON BEHALF OF THE MANUFACTURER MEDIBO MEDICAL PRODUCTS NV (REGISTRATION# 3004468271). LIFT WAS BEING SERVICED BY JJL BIO-MEDICAL. JJL BIO-MEDICAL SWITCHED WIRING AROUND ON UP/DOWN SWITCH LOCATED ON TOP OF MAST CAUSING LIFT TO GO DOWN WITHOUT STOPPING. FAULTY UP/DOWN SWITCH ON TOP OF MAST. THE EVALUATION OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    RESIDENT WAS BEING TRANSFERRED FROM TOILET TO WHEEL CHAIR. WHEN TRANSFERRING THE RESIDENT, THE LIFT WOULD NOT STOP GOING UP AFTER C.N.A. RELEASED HANDSET BUTTON. THE AID TRIED TO STOP THE LIFT, WHEN THE LIFT WOULD NOT STOP GOING UP THE AID WENT TO HELP RESIDENT STAY STANDING UP AND CALLED FOR HELP. A NURSE WAS FIRST TO ARRIVE AND THE AID AND THE NURSE LOWERED THE RESIDENT DOWN ON THE FLOOR. THE RESIDENT WAS IN THE KNEELING POSITION FOR 2-3 MINUTES AND THEN 2 MORE AIDES CAME INTO THE ROOM. THEY THEN PICKED UP THE RESIDENT AND PUT HER IN BED. THE RESIDENT SUFFERED FRACTURED DISTAL FEMURS TO BOTH LEGS; WENT TO THE EMERGENCY ROOM, WHERE THEY WERE ADVISED TO STAY OFF THEIR FEET UNTIL A FOLLOW UP EXAMINATION COULD BE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Hospitalization| R