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

Model Number	MFA2100-L-L1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information collected, including photographic evidence provided by the customer, it was determined that one of the sling loops failed at the stitching.The loop became detached because the required seam had not been formed.The customer was unable to confirm whether the sling had been inspected prior to use.As stated in the instruction for use (ifu 04.Sl.00en rev.11, june 2025), users are required to perform a pre-use inspection of all sling components, including loops and stitching, and are instructed not to use the sling if any part is missing or damaged.Although the pre-use inspection could not be verified in this case, the absence of such an inspection is not considered to be the cause of the failure.The defect originated during manufacturing and would not have been created by the user.Following notification, the manufacturer conducted an internal assessment.The most probable root cause was identified as a sewing machine issue: the bobbin thread ran out during the operation, and the equipment continued its programmed cycle without forming stitches.Because the empty-bobbin condition was not detected, the process proceeded normally but did not generate the required seam.This resulted in an unstitched section of the loop, which subsequently detached during use.Based on the investigation, the internal awareness for manufacturing and quality personnel has been initiated.The arjo device was used for a patient¿s transfer when the event occurred, and it played a role in the event.The loop failed at the stitiching, therefore, the sling did not meet its specification.The complaint was assessed as reportable due to the allegation that one of the sling loops failed at the stitching during patient transfer.
Event or Problem Description
The sling loop broke during a patient transfer.No injury was reported.
Additional Manufacturer Narrative
One of the sling loops failed at the stitching and became detached.The sling is not available for return or evaluation.Process of gathering and analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

• Brand Name: DISPOSABLE LOOP 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: 24257416
• Report Number: 3012292104-2026-00002
• Device Sequence Number: 8326772
• Product Code: FSA
• UDI-Device Identifier: 05055982787994
• UDI-Public: (01)05055982787994(10)2002848257(11)251104
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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
• Device Model Number: MFA2100-L-L1
• Device Lot Number: 2002849257
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown