MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CONCERTO + BASIC; LIFT, PATIENT, NON-AC-POWERED

Model Number	BAB5000-01
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Process of analyzing information is ongoing.Additional information will be provided upon investigation conclusion.Udi number: (b)(4).The device is distributed outside the us and no gudid information exists.
Event or Problem Description
Arjo was notified of a malfunction involving the concerto shower trolley.It was reported that the stretcher was cracked.No injuries were reported.The device was taken out of use and evaluated by an arjo representative.According to the findings, 2 out of 4 screws connecting the stretcher to the frame via a metal plate had fallen out.The stretcher was cracked around the screw holes.The stretcher was subsequently replaced.
Additional Manufacturer Narrative
Process of collecting and analyzing information is ongoing.Additional information will be provided upon investigation conclusion.
Additional Manufacturer Narrative
Based on post-market surveillance data and information gathered during the investigation, it appears that the failure may have occurred due to the an extensive external force that may have been applied to the stretcher (e.G.Uneven weight distribution on the stretcher), which consequently might weaken/wear the stretcher material.The concerto instruction for use (ifu; 04.Ba.05_17) informs that the customer personnel with sufficient device knowledge should perform regular checks of the device: "action before every use: (.) 2.Carry out a thorough inspection for damage.3.If any part is missing or damaged - do not use the product"."every week: check mechanical attachments: (.) check for cracks in the stretcher." the concerto ifu also provides user with supporting figures showing devices areas which should be controlled during preventive maintenance activities.In summary, the stretcher screws were torn out, and therefore the device did not perform as intended.There was no indication that the arjo device was used for a patient treatment when the malfunction occurred.This complaint was decided to be reported to the regulatory authority due to malfunction, which could led to the patient fall and injury occurrence.

• Brand Name: CONCERTO + BASIC
• 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: 23628580
• Report Number: 3007420694-2025-00289
• Device Sequence Number: 9337555
• Product Code: FSA
• UDI-Device Identifier: 05055982788144
• UDI-Public: (01)05055982788144(11)210729
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2026

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: BAB5000-01
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/19/2025; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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