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 Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was inspected by an arjo representative.No malfunction was found.Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.
Event or Problem Description
Arjo was notified of an incident involving a carevo shower trolley.The resident was transferred from a bed to the carevo device using a sliding sling.During the transfer from the bed to the carevo device, the resident slipped between the bed and the carevo device.The carevo device slid away.According to the resident and the caregiver, the brake was not properly applied.At the time, the resident was assisted by 1 carer.The resident was then lifted off the floor using a passive lift.As a consequence the resident sustained bruises on forehead, left hip and had painful left foot.The resident did not go to hospital.She was examined by a nurse specialist.
Additional Manufacturer Narrative
Arjo was notified of an event involving a carevo shower trolley.It was reported that during a transfer (using a sliding sling) from a bed to the carevo device, the resident slipped between the bed and the carevo device.The carevo device slid away as the brake was not properly applied.The resident fell and was then lifted off the floor using a passive lift.As a consequence, the resident sustained bruises on the forehead and left hip, and had pain in the left foot.The resident was examined by a nurse specialist.The carevo inspection revealed no malfunction that could have contributed to the event.All the brakes were checked by the arjo representative and found to be functional.It was not possible to recreate the reported scenario.When the carevo had its brakes applied, it could not shift.It was reported that the brake of the carevo device was not applied properly during the event.Therefore, the carevo device moved away while transferring the resident from the bed to the carevo.This indicates incorrect device usage.The carevo instruction for use (ifu; 04.Ba.08_16) includes the following: - "warning: to avoid falling during transfer, always make sure that the brakes are applied on all equipment being used." - "apply all four castor brakes on the carevo shower trolley." the arjo device was being used for the resident handling at the time of the event.The device met its specifications, as no malfunction was found that could contribute to the event.The complaint decided to be reportable due to the resident fall reported.

• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 21135847
• Report Number: 3007420694-2025-00007
• Device Sequence Number: 15349225
• Product Code: FSA
• UDI-Device Identifier: 05055982787178
• UDI-Public: (01)05055982787178(11)230414
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: BAC1111-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 46 KG