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
Additional Manufacturer Narrative
An inspection of the device was performed.The side supports were in functioning order.It was indicated that both side support catches had worn spring brackets.The conclusions will be provided within the follow-up report once the investigation is completed.
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.
Additional Manufacturer Narrative
The carevo is equipped with two side supports to secure the patient.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 despite 2 worn spring bracket (metal clips that protect the locking handles from rubbing off).These parts do not affect the locking of the side rails which was confirmed during the device inspection as there 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_13) 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 resulting in a serious injury.

• 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: 18510145
• Report Number: 3007420694-2024-00013
• Device Sequence Number: 3665204
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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 Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2021
• 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: Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 65 KG