BEUDAMED
    FDA Adverse Event Death Summary report: N

    SARA FLEX

    MDR report key: 22331031 · Received June 25, 2025

    Report

    Report Number
    9681684-2025-00052
    Event Type
    Death
    Date Received
    June 25, 2025
    Date of Event
    May 28, 2025
    Report Date
    July 30, 2025
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    UDI-DI
    05056097315409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PROCESS OF GATHERING AND ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION PROCESS IS STILL ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED IN NEXT REPORT.

    Additional Manufacturer Narrative · 0

    THE RESIDENT FELL FROM THE SLING USED WITH SARA FLEX. THE INFORMATION RECEIVED SUGGESTS THAT THE SLING MIGHT HAVE BEEN LARGE BECAUSE THE RESIDENT STATED THAT SHE FELT THAT THE SLING WAS TOO LOOSE. THE RESIDENT THEN FELL, BROKE HER BACK, AND SUBSEQUENTLY DIED. THE TIME BETWEEN AN INCIDENT AND PATIENT DEATH IS UNKNOWN. IN THE COMPLAINT THE REPORTER DID NOT DIRECTLY LINK THE PATIENT'S DEATH TO THE FALL OR BROKEN BACK. NO MALFUNCTION WAS FOUND IN THE LIFT OR SLING THAT MAY HAVE CONTRIBUTED TO THE CLAIMED EVENT. THE REPORTED INDICATED THAT THE SLING SIZE WAS SELECTED ACCORDING TO THE RESIDENT¿S WEIGHT BASED ON THE NURSING ASSESSMENT AND ARJO SIZING GUIDE. THE RESIDENT EXPRESSED CONCERN THAT THE SLING FELT TOO LOOSE, WHICH MAY INDICATE THAT WEIGHT-BASED SIZING ALONE WAS INSUFFICIENT TO ENSURE PROPER FIT AND SUPPORT FOR THIS INDIVIDUAL. SLING INSTRUCTIONS FOR USE (04.SF.00-INT1A_8), GUIDES THROUGH THE SIZE SELECTION (THERE IS A SEPARATE CHAPTER), TO ENSURE THE SELECTION OF THE SLING IS BASED ON THE MEASURING OF THE PATIENT'S WAIST. THERE IS ALSO INFORMATION THAT THE SAFE WORKING LOAD FOR ALL SLINGS (S, M, L, XL) IS 200 KG. RELYING ONLY ON BODY MASS MAY RESULT IN INADEQUATE SUPPORT OR A LOOSE FIT, ESPECIALLY FOR INDIVIDUALS WITH ATYPICAL BODY PROPORTIONS. APPROPRIATE SIZING IS ESSENTIAL TO ENSURE COMFORT, SAFETY, AND EFFECTIVE FUNCTIONALITY DURING TRANSFERS. ACCORDING TO THE SARA FLEX INSTRUCTIONS FOR USE (IFU, 04.KL.00.EN_8), ¿BEFORE USE THE CAREGIVER SHOULD ALWAYS CONSIDER THE PATIENT¿S/RESIDENT¿S MEDICAL CONDITION, PHYSICAL AND MENTAL CAPABILITIES. IN ADDITION THE PATIENT/RESIDENT MUST BE ABLE TO BEAR WEIGHT ON AT LEAST ONE LEG AND HAVE SOME TRUNK STABILITY, BE ABLE TO SIT ON THE EDGE OF THE BED, WEIGH IN THE RANGE OF 45 TO 200 KG (99 LB ¿ 440 LB), AND HAVE A HEIGHT WITHIN THE RANGE OF 145 TO 195 CM (4¿8¿ ¿ 6¿4¿). IF THE PATIENT DOES NOT MEET THESE CRITERIA AN ALTERNATIVE EQUIPMENT/SYSTEM SHALL BE USED.¿ ARJO RECEIVED INFORMATION THAT THE RESIDENT¿S ARMS WERE POSITIONED INSIDE THE SLING, RATHER THAN ON THE DESIGNATED GRIP HANDLES DURING THE EVENT. IT MAY HAVE REDUCED UPPER-BODY STABILITY DURING TRANSFER AS THE GRIP HANDLES ARE DESIGNED SPECIFICALLY FOR THE PATIENT TO HOLD ONTO DURING THE SIT-TO-STAND MOVEMENT. ACCORDING TO IFU, THE CAREGIVER SHOULD ¿ASK OR ASSIST PATIENT TO PLACE HIS/HER HANDS ON THE PATIENT/RESIDENT HANDLES.¿ SUM UP, THE INCIDENT APPEARS TO HAVE RESULTED FROM A POTENTIAL UNINTENTIONAL USE ERROR (SLING MAY NOT HAVE BEEN A PROPER SIZE BASED ON THE MEASURING OF THE PATIENT'S WAIST). NO DEFICIENCIES WERE IDENTIFIED IN THE LIFT OR SLING; BOTH MET THEIR SPECIFICATIONS. THEY WERE USED AS A SYSTEM FOR PATIENT TRANSFER AND THEREFORE PLAYED A ROLE IN THE INCIDENT. THIS COMPLAINT DECIDED TO BE REPORTABLE DUE TO THE PATIENT¿S FALL.

    Description of Event or Problem · 0

    THE RESIDENT FELL FROM THE SLING USED WITH SARA FLEX. THE INFORMATION RECEIVED SUGGESTS THAT THE SLING MIGHT HAVE BEEN LARGE. THE RESIDENT STATED THAT SHE FELT THAT THE SLING WAS TOO LOOSE. THE RESIDENT THEN FELL, BROKE HER BACK, AND SUBSEQUENTLY DIED. THE TIME BETWEEN AN INCIDENT AND PATIENT DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367941 SARA FLEX LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. HEB0000 05056097315409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death