BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIVERSAL SPACER MEDIUM SLING

    MDR report key: 10449099 · Received August 25, 2020

    Report

    Report Number
    3007802293-2020-00017
    Event Type
    Death
    Date Received
    August 25, 2020
    Date of Event
    August 11, 2020
    Report Date
    September 8, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6: PATIENT CODE 1802 DEATH WAS ADDED. ADDITIONAL NARRATIVE: UPON INTERVIEW BETWEEN THE ACCOUNT MANAGER AND THE SITE, THE CONCLUSION WAS REACHED THAT THE SHOULDER LOOP OF THE SLING WAS NOT SECURED IN THE BOTTOM OF THE HOOK AS THE STAFF MEMBER HAD THOUGHT. IT WASN'T IN THE CARRYBAR PROTECTED BY THE SAFETY LATCH, AS IT APPEARED TO THE STAFF WHEN HOOKING UP THE SLING; THEY PROCEEDED THINKING THEY WERE SAFE TO DO SO. THE SHOCK OF THE FOOT GIVING WAY AND THE WEIGHT OF THE RESIDENT AGAINST THE SHOULDER STRAP CAUSED THE LOOP TO FREE FROM THE EDGE OF THE HOOK AND THE RESIDENT FALLING TO THE GROUND. THE ROOT CAUSE OF THE INCIDENT WAS USER ERROR. SERVICE VISITED THE FACILITY ON SEPTEMBER 1ST AND INSPECTED THE INVOLVED PRODUCTS. HE CONFIRMED ALL WAS IN WORKING ORDER. THE SLING WAS A RECENT PURCHASE WITH NO INTEGRITY ISSUES OR CONCERNS WITH WEAR. THE ACCOUNT MANAGER RETURNED TO THE FACILITY AND CONDUCTED RE-TRAINING WITH PHYSIOTHERAPY STAFF, EDUCATORS, AND NURSING STAFF IN THREE SEPARATE SESSIONS ON (B)(6).

    Additional Manufacturer Narrative · 1

    THE RESPONSIBLE ACCOUNT MANAGER VISITED THE FACILITY ON THE 21ST AND 23RD TO GATHER DETAILS OF THE INCIDENT. THE INVOLVED PRODUCTS WERE INSPECTED AND NO FAILURE IDENTIFIED. SERVICE WILL VISIT THE FACILITY TO CONDUCT A THOROUGH INSPECTION ON THE LIFT, AND THE ACCOUNT MANAGER WILL PRODUCT FURTHER TRAINING FOR THE FACILITY FOR SLING APPLICATION BEST PRACTICES. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THESE ACTIONS ARE COMPLETE.

    Description of Event or Problem · 1

    TWO STAFF MEMBERS WHERE COMPLETING A PATIENT TRANSFER FROM A BRODA CHAIR TO THE BED. THE STAFF ATTACHED A SIDE OF THE SLING AND MADE NOTE OF PUTTING ALL THREE LOOPS ON THE CARRY BAR, THEY WERE PROCEEDING WITH THE TRANSFER THINKING THAT THE SLING WAS ATTACHED PROPERLY. THE RESIDENT'S FOOT BECAME STUCK UNDER THE ACTUATOR OF THE CHAIR. WHEN THE CHAIR WAS REPOSITIONED, HER FOOT GAVE WAY AND SHE FELL BACK AND TO THE LEFT AND HIT HER HEAD. IT WAS ALSO AT THAT TIME THE STAFF MEMBER NOTICED THAT THE LEFT SHOULDER STRAP WAS NO LONGER ATTACHED. SHE WAS LOWERED THE REST OF THE WAY TO THE FLOOR AND MEDICAL ASSISTANCE WAS REQUESTED. EMTS WERE CALLED AND PRIMARILY ADDRESSED THE HEAD INJURY. SHE WAS TREATED AND REMAINED AT THE FACILITY. SHE WAS TRANSFERRED USING THE SLING OVER THE NEXT FEW TWO DAYS WHICH APPEARED TO IRRITATE HER HIP. ON THE 14TH, STAFF NOTED BRUISING ON HER HIP; SHE WAS ADMITTED TO HOSPITAL AND RELEASED SAME DAY. LATER, A HAIRLINE FRACTURE ON BOTH HER LEFT AND RIGHT HIP WERE FOUND. SHE PASSED AWAY DUE TO COMPLICATIONS FROM HER HIP INJURIES ON THE 16TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913727 UNIVERSAL SPACER MEDIUM SLING PATIENT SLING FSA HANDICARE USA INC. 8A4400

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Death| H