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

Model Number	BAC1111-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/09/2023
Type of Reportable Event	Death
Event or Problem Description
Arjo was notified about an event with involvement of carevo shower trolley.After contacting the facility, it was reported that the resident had fallen out of the device and died as a result of the fall.Based on the information received, both side supports of the carevo were opened to transfer the resident to a bed.One of the caregivers was at the head of the carevo, while the second caregiver was at the foot section of the device.One of the caregivers went towards the bed to transfer the resident.At this point, the resident turned around to where the bed was not and fell to the floor.

• 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: 17207425
• Report Number: 1419652-2023-00042
• Device Sequence Number: 5540578
• Product Code: FSA
• UDI-Device Identifier: 05055982787178
• UDI-Public: (01)05055982787178(11)200211
• 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): 06/27/2023
• Report Date (Section F): 06/27/2023

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 the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/30/2023
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2023
• 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: Death
• Patient Sex: Female
• Patient Weight: 50 KG
• Date Report Sent to FDA: 06/27/2023