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

Model Number	MFA1000M-XL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing, and results will be updated in the final report.H3 other text: the sling was discarded by staff after the incident.
Event or Problem Description
A patient fell onto their bed after the sling broke during transfer.The sling was discarded by staff after the incident.No injury was reported.
Additional Manufacturer Narrative
The customer reported that they had a patient in a sling and the sling broke.The patient fell onto their bed.There was no injury.The sling was thrown away after the incident, therefore no evaluation was conducted.Customer informed that the sling broke "at the top l where the plastic clip attaches." from customer's words, it has been deduced that the top l refers to the shoulder strap.Shoulder strap is stitched to the sling body creating an l shape.Yet, without product on hand it is not possible to determine how the strap broke, therefore without product availability, the root cause of why strap broke cannot be determined.Product instructions for use (04.Sc.00-9en) was also checked.The instructions include the following: "before first use check all parts of the sling.If any part is missing or damage - do not use the sling." sum up, the sling failed to meet its specification as it broke during use, it was involved in the incident, since the broken strap caused the patient falling onto the bed.There was no injury.This incident has been deemed reportable due to allegation of broken strap during use causing patient's falling.

• Brand Name: PASSIVE CLIP SLING
• 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: 22882790
• Report Number: 3012292104-2025-00004
• Device Sequence Number: 9640637
• Product Code: FSA
• UDI-Device Identifier: 05055982770897
• UDI-Public: (01)05055982770897(10)2002813630(11)250416
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

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: MFA1000M-XL
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/09/2025; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown
• Patient Weight: 127 KG