BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOYER PRESENCE LIFT W/QUICKFIT SLING

    MDR report key: 2973476 · Received February 15, 2013

    Report

    Report Number
    3009402404-2013-00002
    Event Type
    Death
    Date Received
    February 15, 2013
    Date of Event
    April 10, 2012
    Report Date
    February 8, 2013
    Manufacturer
    JOERNS HEALTHCARE MFG INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE FAILURE; LIFT AND SLING FUNCTIONS AS INTENDED. DEVICE IS STILL IN USE PER THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER BY ATTORNEY REPRESENTING THE INJURED PARTY WHO WAS A RESIDENT AT (B)(6). ATTORNEY STATED INCIDENT HAPPENED LAST SPRING/SUMMER TIME FRAME. RESIDENT FELL AND HAS PASSED AWAY SINCE THE INCIDENT [UNSURE IF THERE IS A DIRECT RELATIONSHIP]. ATTORNEY ALSO STATED THAT SOMEONE FROM JOERNS DID AN IN-SERVICE ON THE LIFTS AT THE FACILITY. UPON FURTHER INVESTIGATION THE FOLLOWING INFORMATION WAS DISCOVERED: IN-SERVICE AND TRAINING DID HAPPEN AT FACILITY ON (B)(4) 2012; FACILITY HAS THE TRAINING RECORDS. PER FACILITY THEY WERE TRANSFERRING THE RESIDENT ATTEMPTING TO WEIGH HER THE RESIDENT HAD BEEN MOVING IN THE LIFT [THOUGHT SHE HAD A SEIZURE] AND FELL OUT OF THE SLING LANDING ON THE FLOOR. FACILITY DID NOT KNOW IF RESIDENT FELL BACKWARDS OUT OF THE SLING. RESIDENT WAS SENT TO THE HOSPITAL FOR MEDICAL EXAM RESULTS WERE LACERATION TO HEAD, CLOSED HEAD INJURY WITH SUBDURAL HEMATOMA, MULTIPLE CERVICAL SPINAL FRACTURES. NO PRODUCT FAILURE PRODUCT IS STILL IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69533 HOYER PRESENCE LIFT W/QUICKFIT SLING PATIENT LIFTER FNG JOERNS HEALTHCARE MFG INC. PRESENCE W/SLING

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Hospitalization