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

Model Number	BAC1101-01
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The conclusions will be provided within the follow-up report once the investigation is completed.
Event or Problem Description
Arjo was notified about an event with involvement of a carevo shower trolley.It was reported that a resident fell out of the device.At the time of turning the resident to the right side, the side support opened.The resident suffered a neck pain (cervicalgia) and was treated with cervical collar.
Additional Manufacturer Narrative
The device was inspected by an arjo technician.According to the information received, the side support could have been unlocked by shaking this part strongly.The carevo is equipped with two side supports to secure the resident.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 instruction for use (ifu; 04.Ba.08_13en) 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." based on the information gathered in the course of this investigation, the incident related to unexpectedly opening of the side support could occur if a precise sequence of movements happened to detach carevo safety side support: strong push directed upwards on the side support handle.Fast pulling on the side support handle in the downwards direction.To sum up, the carevo did not meet its performance specifications as the side support opened unintended.The event occurred during use with the resident.This complaint was decided to be reported to regulatory authority due to customer allegation which stated that the resident fell off the device.Minor injury was 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17842171
• Report Number: 3007420694-2023-00233
• Device Sequence Number: 12536388
• Product Code: FSA
• UDI-Device Identifier: 05055982787161
• UDI-Public: (01)05055982787161(11)200525
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2023

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: BAC1101-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 09/08/2023; 09/08/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/18/2023; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2020
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 54 KG