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

Model Number	BAB1000-01
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Limb Fracture (4518)
Type of Reportable Event	Serious Injury
Event or Problem Description
Arjo was informed about an incident with involvement of a concerto shower trolley.It was reported that the resident fell out on the floor, when the side support unlocked and moved to lower position.The patient was in pain, had a swollen knee and was taken to the emergency room for an x-ray.It was confirmed that patient sustained the femoral fracture.

• 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: 12224664
• Report Number: 1419652-2021-00025
• Device Sequence Number: 17237538
• Product Code: FSA
• UDI-Device Identifier: 05055982788083
• UDI-Public: (01)05055982788083(11)201118
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 07/26/2021
• Report Date (Section F): 07/26/2021

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: BAB1000-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/08/2021
• Device Age: 7 MO
• Event Location: Other
• Date Report to Manufacturer: 07/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2021
• 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; Required Intervention
• Date Report Sent to FDA: 07/26/2021