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

Model Number	BAC1111-01
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Swelling (2091)
Date of Event	03/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Arjo was notified about an event with involvement of carevo shower trolley.It was reported that when the caregiver turned the patient over, the side support opened and the patient fell to the ground.The patient was injured and taken to the emergency room.According to the received information the patient sustained the following injuries - broken femur, swollen nose, swollen forehead.The patient was hospitalized.

• 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: 9876638
• Report Number: 1419652-2020-00018
• Device Sequence Number: 16798566
• Product Code: FSA
• UDI-Device Identifier: 05055982787178
• UDI-Public: (01)05055982787178(11)190612
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2020
• Report Date (Section F): 03/25/2020

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: 03/19/2020
• Device Age: 9 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2020
• 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; Other
• Date Report Sent to FDA: 03/25/2020