BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMEX

    MDR report key: 2193005 · Received July 25, 2011

    Report

    Report Number
    2428983-2011-00002
    Event Type
    Death
    Date Received
    July 25, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 22, 2011
    Manufacturer
    APEX HEALTH CARE MFG INC.
    Product Code
    FNG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GF HEALTH PRODUCTS, INC. (DEVICE IMPORTER/DISTRIBUTOR) SENT A QUALITY MANAGER TO THE PT'S HOME ON TUESDAY (B)(6) 2011 TO INSPECT THE LF 1030 HYDRAULIC LIFT, TAKE DIGITAL PHOTOGRAPHS, VIDEO, AND INTERVIEW THE CAREGIVER AND PT'S DAUGHTER. THE ATTACHED REPORT REFLECTS NO MANUFACTURING DEFECT. THE PT SHOULD NOT HAVE BEEN LEFT UNATTENDED IN THE LIFT. THE MAINTENANCE SCHEDULE, SAFETY INSTRUCTIONS AND WARNINGS OUTLINED IN THE OWNER'S INSTRUCTION MANUAL HAD NOT BEEN FOLLOWED. THE INITIAL REPORTER (DEALER) HAS SIGNED ACKNOWLEDGEMENT OF RECEIPT. THE LIFT IS SCHEDULED TO BE PICKED UP ON TUESDAY, (B)(6) 2011 BY A GF HEALTH PRODUCTS, INC. REPRESENTATIVE AND SENT TO (B)(6) FOR AN INDEPENDENT THIRD PARTY EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011 AT APPROXIMATELY 9 AM, THE CAREGIVER STATED SHE HAD THE PT IN AN UPRIGHT POSITION IN THE SLING AND ON THE LIFT. THE CAREGIVER WAS ATTEMPTING TO MOVE THE PT FROM THE BED TO THE DINING CHAIR. AFTER THE PT WAS ON THE LIFT, SHE STATED SHE PUT THE REAR CASTER BRAKES ON, AND LEFT THE PT (UNATTENDED) TO GET THE DINING CHAIR LOCATED BY THE BEDROOM DOOR. WHEN THE CAREGIVER TURNED SHE NOTICED THE LIFT WAS MOVING TOWARDS THE DOOR. SHE RUSHED TO THE FRONT OF THE LIFT AND TRIED TO STOP IT. SHE ATTEMPTED TO GRAB THE HANDLES. THE CAREGIVER WAS UNABLE TO STOP THE LIFT. SHE STATED THE LIFT HIT THE DOOR AND THE PT FELL ON THE FLOOR HITTING HIS HEAD BY THE DOOR FRAME. THEN THE LIFT UPPER ASSEMBLY FELL OVER ON THE PT. AFTER THE INCIDENT, THE CAREGIVER CARRIED THE PT FROM THE FLOOR TO THE BED AND TELEPHONED THE PT'S DAUGHTER. THE PT WAS LATER TRANSPORTED TO THE HOSPITAL AND DIED AT APPROXIMATELY 7 PM FROM INTERNAL BLEEDING IN THE PLURAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX HYDRAULIC PATIENT LIFT FNG APEX HEALTH CARE MFG INC. LF 1030 31422

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death