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	Fall (1848); Bone Fracture(s) (1870)
Date of Event	05/24/2022
Type of Reportable Event	Death
Event or Problem Description
Arjo was notified about an event involving a concerto shower trolley.The following information was gathered: after washing, the resident was transferred to the resident¿s room with the concerto shower trolley.The trolley was positioned parallel to the bed.It was reported that the side rails were up.While getting dressed, the resident turned towards the bed, the side rails allegedly loosened and the resident then fell head first onto the floor.As a consequence, the resident sustained broken ribs, broken collarbone and there was minimal bleeding.It was reported that the resident died 5 days after the event.

• 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
• MDR Report Key: 14787179
• Report Number: 1419652-2022-00030
• Device Sequence Number: 4895791
• Product Code: FSA
• UDI-Device Identifier: 05055982788144
• UDI-Public: (01)05055982788144(11)210913
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/23/2022
• Report Date (Section F): 06/23/2022

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: BAB5000-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/25/2022
• Device Age: 8 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2022
• 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: 75 KG
• Date Report Sent to FDA: 06/23/2022