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	Bruise/Contusion (1754); Laceration(s) (1946)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The carevo is equipped with two side supports to secure the patient.The side support has three positions, presented in the instructions for use (ifu): inner, outer and folded down.Each side support in the carevo has two handles.By using them at the same time, the side support can be folded or unfolded.The device inspection conducted by an arjo technician revealed and confirmed that the carevo side supports can be locked and unlocked correctly.It was not possible to recreate the event.The manufacturer investigation revealed that precise sequence of movements has to happen to detach carevo safety side support.The instruction for use (ifu) (04.Ba.08_11) provides information that when side supports are raised to a desired position they should lock and click into place.A caregiver should ensure that the side supports are in locked position e.G.: ¿lift the operating handles and raise/lower the side support to the selected position until it locks and clicks into place¿ ¿warning: to avoid the patient from falling out of the device make sure that all side supports are in a locked position.¿ to sum up, the carevo did not meet its performance specifications as side support opened unintended.The event occurred during use with the resident.The complaint decided to be reportable due to the resident fall reported.
Event or Problem Description
Arjo was notified of an event involving a carevo shower trolley.It was indicated that the caregivers wanted to wash the resident's back and rolled the resident over.The side support of the device opened, causing the resident to fall from the device.As a result, the resident sustained a facial bruise and a small cut above the right eye.The resident was taken to a local hospital and is now back in the care home.

• 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: 19076982
• Report Number: 3007420694-2024-00096
• Device Sequence Number: 6030595
• Product Code: FSA
• UDI-Device Identifier: 05055982787178
• UDI-Public: (01)05055982787178(11)181213
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2018
• 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 Sex: Female