BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679

    MDR report key: 6710856 · Received July 13, 2017

    Report

    Report Number
    3008262382-2017-00014
    Event Type
    Death
    Date Received
    July 13, 2017
    Date of Event
    March 11, 2015
    Report Date
    June 13, 2017
    Manufacturer
    INVACARE REHABILITATION EQUIPMENT CO.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTORNEY STATED THAT THERE IS NO ALLEGATION OF MALFUNCTION OR DEFECT AGAINST THE INVACARE EQUIPMENT. THE SLING IS BEING RETAINED BY THE PLAINTIFF'S ATTORNEY. THE LIFT WAS RETURNED TO THE DEALER WHERE IT WAS CHECKED. THE LIFT WAS PUT BACK IN SERVICE AFTER THERE WERE NO DEFECTS DISCOVERED AND IT WAS FOUND TO BE IN GOOD WORKING CONDITION. THE FAMILY FEELS THE WRONG EQUIPMENT FOR THE END USERS MEDICAL CONDITIONS AND NEEDS WAS SELECTED AND IMPROPER USE OF THE EQUIPMENT CAUSED THE END USER TO PASS AWAY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    AN ATTORNEY, REPRESENTING THE THERAPIST STATED THE PATIENT FAMILY IS ALLEGING THAT THE PATIENT WAS INAPPROPRIATELY TRANSFERRED WITH A 9805P AND AN R117 SLING BY A PHYSICAL THERAPIST AND A HOME CAREGIVER ON (B)(6)2015. THE PATIENT WAS ABOUT 375-400 LBS AND APPROXIMATELY 69 INCHES LONG. THE PATIENT PASSED AWAY. THE CLAIM IS THAT THE LIFT SLING WOULD RESTRICT HIS BREATHING. THE PATIENT HAS RESPIRATORY ISSUES. THE PATIENT HAD FALLEN WITH A LIFT PREVIOUSLY. THE PATIENT HAD HIGH ANXIETY AND THEY BELIEVE THAT WAS THE CAUSE AND THE ATTORNEY STATED HE BELIEVES THE LIFT IS A MISS DIRECT. THE ATTORNEY DID NOT HAVE THE LIFT SERIAL NUMBER. THE ATTORNEY STATED THE LAWSUIT IS AGAINST THE DEALER, NURSE AND THERAPIST. THE ATTORNEY STATED THEY WORKED THE PATIENT SLOWLY UP TO ACTUALLY BEING TRANSFERRED WITH THE LIFT TO EASE THE PATIENT ANXIETY. THE ATTORNEY STATED THE PATIENT'S COUNCIL HAS THE SLING AND THE LIFT HAS BEEN RETURNED TO PROVIDER AND OUT IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493303 HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679 NON-AC POWERED PATIENT LIFT FSA INVACARE REHABILITATION EQUIPMENT CO. NA:9805P

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death