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	Device Fell (4014)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	10/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided upon investigation conclusion.
Event or Problem Description
Customer reported that during hygiene of the resident in the shower stretcher, while making a postural change, the right-side rail of the shower stretcher opened causing the resident to fall.The patient sustained skull and face contusion, scalp and neck contusion.
Additional Manufacturer Narrative
Customer reported that during hygiene of the resident in the concerto shower stretcher, while making a postural change, the right side rail of the shower stretcher opened causing the resident to fall.The resident sustained a skull and face contusion, scalp and neck contusion.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.The device was not serviced by arjo but internally by the customer.The device inspection and photos provided showed that the concerto right side rail was bent with locking hook (black catch) not locking in place.The photos provided suggests that this part might have been defective prior to the incident and the defect might not have been noticed by the caregiver.Additionally, the resident's postural change with the bent side support could cause the side support to open and the resident to fall.Following the device instruction for use (ifu;04.Ba.05_17): -"actions before every use (.) if any part is missing or damaged - do not use the product!" -"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" according to the preventive maintenance schedule, the functionality test of the concerto should be performed every week and this includes test for "catches on the side supports".Moreover, the catches should be replaced every year by the qualified personnel service.Based on the information gathered during the investigation, it appears that the cause of the resident's fall could be a failure to follow the instructions for use.In summary, the concerto device did not meet performance specifications due to damages found.The event occurred during use with the resident.The complaint decided to be reportable due to the patient's fall reported.
Additional Manufacturer Narrative
Process of collecting and analyzing information is ongoing.Additional information will be provided upon investigation conclusion.

• 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: 20769937
• Report Number: 3007420694-2024-00285
• Device Sequence Number: 11865348
• Product Code: FSA
• UDI-Device Identifier: 05055982788144
• UDI-Public: (01)05055982788144(11)210204
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/08/2025

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: 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: 10/28/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/19/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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 Age: 85 YR
• Patient Sex: Female
• Patient Weight: 64 KG