MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MAXI TWIN; LIFT, PATIENT, NON-AC-POWERED

Model Number	KTBB4BSX2WW
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.The results will be provided when the investigation is completed.D4: the device is distributed outside the us and no gudid information exists.
Event or Problem Description
Following the information reported, the maxi twin passive floor lift collapsed when the caregivers tried to lift the patient for transfer from the chair to the bed.When this occurred, the patient was lowered back into the chair.No injuries were sustained.
Additional Manufacturer Narrative
Inspection of the device revealed that the only damage was a fractured plastic cover on the pivot bolt (housing covering the bolt between spreader bar and mast).It remains uncertain whether the damage of the cover was a direct consequence of the reported incident.According to the incident description, the collapse allegedly occurred during raising of the patient, whereas the observed cover damage is more consistent with obstruction during lowering.The obstruction scenario does not result in a collapse of the device as reported by the customer, but rather prevents any further lowering of the lift.As no mechanical or electronic fault was detected that could cause collapse, the root cause of the reported lift collapse cannot be determined with the available evidence.This complaint is considered a singular occurrence.To summarize, the lift did not meet specifications as the plastic cover on the pivot bolt was fractured.The device was used to transfer the patient.The complaint was deemed reportable due to the customer's allegation regarding lift collapse.
Event or Problem Description
The incident occurred in a private home during an attempted patient transfer using a maxi twin passive floor lift.While carers were raising the patient from a chair to a bed, the lift allegedly collapsed.The patient was safely returned to the chair, and no injuries were reported.Following the event, five individuals assisted in facilitating the patient¿s transfer back to the bed.The patient¿s wife contacted a third-party service provider responsible for maintaining the lift to arrange inspection and repair.Then, the lift was returned to the arjo service center for inspection.

• Brand Name: MAXI TWIN
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 23461400
• Report Number: 3007420694-2025-00273
• Device Sequence Number: 10381213
• Product Code: FSA
• UDI-Device Identifier: 05055982787154
• UDI-Public: (01)05055982787154(11)230504
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: KTBB4BSX2WW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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 Sex: Unknown