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

Model Number	BAC1111-01
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Arjo was notified of an incident involving a carevo shower lift trolley.It was reported that a patient was turned onto their left side so that the caregiver could position the sling.At that moment, the side support of the carevo opened, and the patient fell.As a result, the patient sustained a broken nose and required sixteen stitches.It was also indicated that several lateral mobilizations had been performed before the fall.The device was subsequently inspected by an arjo technician, who found no malfunction that could have contributed to the event.According to additional information received, the caregiver had closed the side support with one hand while the patient was already positioned in the carevo.In this situation, only the handle located at the foot end can engage properly, making it possible for the patient to accidentally open it with their foot while lying on their side.Furthermore, the patient¿s legs were outside the carevo, and it is likely that she may have touched the handle with her heel.

• Brand Name: CAREVO
• 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
• MDR Report Key: 24289481
• Report Number: 1419652-2026-00005
• Device Sequence Number: 13113731
• Product Code: FSA
• UDI-Device Identifier: 05055982787178
• UDI-Public: (01)05055982787178(11)190301
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2026
• Report Date (Section F): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: BAC1111-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/14/2026
• Device Age: 5 YR
• Event Location: Other
• Date Report to Manufacturer: 02/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 02/09/2026