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); Head Injury (1879)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Arjo was notified of an event involving a carevo shower trolley.The event occurred during a patient treatment when the patient was on the side of the carevo and the side supports were in the middle position.It was reported that the side support opened, causing the patient to fall to the ground.As a result, the patient sustained head trauma and a shoulder fracture.This required hospitalization.The device was inspected by an arjo technician.Evaluation of the device showed visual damages on both side supports.The device passed function test results.

• 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: 21341937
• Report Number: 1419652-2025-00008
• Device Sequence Number: 13001711
• Product Code: FSA
• UDI-Device Identifier: 05055982787178
• UDI-Public: (01)05055982787178(11)210108
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2025
• Report Date (Section F): 02/10/2025

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: 01/13/2025
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2025
• 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: Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Date Report Sent to FDA: 02/10/2025