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); Bone Fracture(s) (1870); Head Injury (1879)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Process of analyzing information is ongoing.Additional information will be provided upon investigation conclusion.
Event or Problem Description
Arjo was notified of an event involving a carevo shower trolley.The event occurred during a patient treatment when the patient was on the side of the carevo and the side supports were in the middle position.It was reported that the side support opened, causing the patient to fall to the ground.As a result, the patient sustained head trauma and a shoulder fracture.This required hospitalization.The device was inspected by an arjo technician.Evaluation of the device showed visual damages on both side supports.The device passed function test results.
Additional Manufacturer Narrative
Process of collecting and analyzing information is ongoing.Additional information will be provided upon investigation conclusion.
Additional Manufacturer Narrative
Arjo was informed of an incident involving a carevo shower trolley during patient treatment.According to the information provided, safety side was in outer position (b).The caregiver was standing next to the side support that opened and was unable to prevent the patient from falling.The patient fell to the ground when the side support opened, resulting in head trauma and a shoulder fracture, which required hospitalization.The technician noted visual damages on both side supports, but this did not affect their ability to lock in position.Only a specific sequence of actions (e.G., hitting/pressing the safety side handle with a leg while the other handle is already unlocked) allowed the event to be recreated from caregiver's perspective.The carevo is equipped with two side supports to secure the patient.Each side support has two handles, which can be used simultaneously to fold or unfold the support.The side support has three positions, presented in the instructions for use (ifu) 04.Ba.08_13en: inner (a), outer (b) and down folded (c).The design of the device does not assure the locking mechanism comes back to its original position (lock) after accidental unlocking of one of side supports.So, if one of the side support handles gets unlocked, side support is only locked with one handle.Based on post-market survaillance data and complaint review, if one handle is accidentally unlocked (e.G., hit by a leg) and the caregiver then accidentally opens the second handle, the side support can unintentionally open.The movement of the safety side depends on its initial position (in this case, it moved from outer position (b) to down folded position (c)).If the handles are used correctly (the caregiver is in an ergonomic position and the side supports are properly latched), the side support cannot be lowered.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 opening 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 the investigation, the cause of the unintended opening of the side support was usage error.A complex sequence of actions may lead to the unintentional opening of the side supports, requiring several factors to act at the same time.To sum up, the carevo failed to meet its performance specifications as side support opened unintended.The event occurred during use with the patient.The complaint was assessed as reportable due to the allegation of patient fall.

• 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: 21341938
• Report Number: 3007420694-2025-00031
• Device Sequence Number: 13001712
• Product Code: FSA
• UDI-Device Identifier: 05055982787178
• UDI-Public: (01)05055982787178(11)210108
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2025

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: 01/13/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/11/2025; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2021
• 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: 87 YR
• Patient Sex: Female
• Patient Weight: 50 KG