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); Head Injury (1879); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Arjo was notified of an event involving a carevo shower trolley.It was reported that while bathing a patient using the carevo shower trolley, the caregivers pulled the patient's hands and body to the left side, leaning against the caregiver, when the side support released unintentionally and the patient started to fall onto the caregiver.The caregiver held the patient's body and both the patient and caregiver fell to the ground with the side support.As a result, the patient's head hit the floor and began to bleed.An ambulance was called and the patient was taken to the hospital.A computed tomography (ct) scan showed a cerebral hemorrhage.The customer was interviewed the day after the incident, and during the interview, information was obtained that the patient was conscious and the hemorrhage had stopped.According to the customer, the caregiver was also injured - pain to the back and hand, but the injury did not require treatment.

• 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: 18510146
• Report Number: 1419652-2024-00006
• Device Sequence Number: 3665205
• Product Code: FSA
• UDI-Device Identifier: 05055982787178
• UDI-Public: (01)05055982787178(11)210317
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 01/15/2024
• Report Date (Section F): 01/15/2024

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: 12/18/2023
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2024
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Date Report Sent to FDA: 01/15/2024