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

Model Number	BAB1000-01
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerto device is equipped with two side supports located on each side.To release it from the up position the two black catches need to be pressed at the same time.When raising the side support, the two catches shall be snapped into place.During the evaluation of the device, it was not possible to recreate the alleged scenario.The side support locking mechanism functioned correctly, locking and unlocking as intended.No other issues were detected that could have contributed to the incident.Based on the post-market surveillance data review and the results of the investigation, it appears that the side support might not have been locked or checked for locking during use.This is in line with the information received that customer staff were unsure whether the side support was properly locked or not.The instruction for use (ifu; 04.Ba.05_15) states: - "warning: to avoid resident falling out of the device, make sure that all side supports are in a locked position." - "when raising the side support, make sure the two catches snap into place".Also, the patient should be positioned in the middle of the concerto stretcher: - "warning: to avoid falling, make sure that the patient is positioned in accordance with this ifu." "both caregivers need to help the patient towards the middle of the concerto/basic shower trolley." in conclusion, the device was used for patient handling at the time of incident occurrence and in that way contributed to the event.No device malfunction was detected during the evaluation conducted after the incident, and the device was found to be in accordance with the manufacturer¿s technical specifications.However, as per the customer¿s allegation the side support unlocked, so the device did not perform as intended.This complaint was decided to be reported to the competent authorities due to indication of the patient fall which resulted in the injury.
Event or Problem Description
Arjo was notified of an event related to a concerto shower trolley.It was reported that a patient fell from the device as the side support opened.The patient sustained head injury but no more details regarding the patient's treatment were released by the facility.

• 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: 21629246
• Report Number: 3007420694-2025-00066
• Device Sequence Number: 8925526
• Product Code: FSA
• UDI-Device Identifier: 05055982788083
• UDI-Public: (01)05055982788083(11)190509
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 03/18/2025

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
• Operator of Device: Other
• Device Model Number: BAB1000-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2019
• 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