MAUDE Adverse Event Report: ARJO DOMINICAN REPUBLIC CLIP SLING ¿ PADDED LEGS; LIFT, PATIENT, NON-AC-POWERED

Model Number	MAA4000M-XL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Abrasion (1689); Fall (1848); Distress (2329)
Date of Event	11/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is distributed outside the us and no gudid information exists.The investigation is ongoing.Results of the analysis will be provided to the follow-up report.
Event or Problem Description
The customer reported that a resident fell from an arjo sling that was being used with a non-arjo lift (joyincare).During a visit to the customer¿s facility, it was clarified that the fall was caused by the detachment of the left leg clip from the lift.Immediately before it detached, an unrecognizable sound (a snap) was heard by the caregiver.The care recipient was being guided to the floor and sustained a scrape on the head; no medical or surgical intervention was required.The caregiver reported psychological distress, including sleep disturbance, and plans to see a trauma therapist.
Additional Manufacturer Narrative
Based on the collected information, the resident fell from the arjo sling due to the leg clip detachment.The arjo sling was used with a non-arjo lift, identified as the powermove mini ttm 1060577, manufactured by joyincare (non-arjo).Under no circumstances should arjo¿s clip attachment system be used with third-party patient transfer equipment, as arjo¿s spreader bar lugs have been exclusively designed to work with arjo¿s clip slings.According to arjo clip slings instructions for use (ifu 04.Sc.00-9en from dec/2023): ¿the passive clip sling should be used together with arjo lift devices in accordance with the allowed combinations specified in the instructions for use (ifu).¿ as per ifu, the involved sling model maa4000m can be used only with maxi twin compact, maxi lite, maxi 500, maxi twin, maxi move, or maxi sky.The ifu also states: ¿warning: to avoid injury, always follow the allowed combinations listed in this ifu.No other combinations are allowed.¿ ¿the passive clip slings are intended to be used with arjo lifters equipped with clip spreader bars only.¿ the event was caused by the use of an arjo sling with a non-arjo lift.No manufacturing issues were identified, and the sling was confirmed to be within specification.The device was being used with the resident at the time the reported issue occurred.The complaint was deemed reportable due to the allegation that a resident fell.The fall was caused by the detachment of the left leg clip from the non-arjo lift, and therefore the arjo device was involved in the reported event.

• Brand Name: CLIP SLING ¿ PADDED LEGS
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJO DOMINICAN REPUBLIC; building 9 piisa industrial pa km18 1/2 antigua carretera s; itabo 10903 ; DR 10903
• Manufacturer (Section G): ARJO DOMINICAN REPUBLIC; building 9 piisa industrial pa km18 1/2 antigua carretera s; itabo 10903 ; DR 10903
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 23847330
• Report Number: 3012292104-2025-00005
• Device Sequence Number: 9543834
• Product Code: FSA
• UDI-Device Identifier: 05055982796606
• UDI-Public: (01)05055982796606(11)231212
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: MAA4000M-XL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 70 KG