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); Laceration(s) (1946)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Arjo was notified of an event involving a carevo shower trolley.It was indicated that the side support opened unintended, causing the patient to fall from the carevo.The patient was caught by the caregiver.As a result, the patient sustained scratches on the left knee.
Additional Manufacturer Narrative
The device was inspected by an arjo technician.The conclusions will be provided within the follow-up report once the investigation is completed.
Additional Manufacturer Narrative
Process of analyzing information is ongoing.Additional information will be provided upon investigation conclusion.
Additional Manufacturer Narrative
Arjo was notified of an event involving a carevo shower trolley.It was indicated that the side support opened unintended, causing the patient to fall from the carevo.The patient was caught by the caregiver.As a result, the patient sustained scratches on the left knee.It was reported that the side support on the right side unlocked suddenly from the comfort (outer) position.The caregiver had both hands on the resident, when it opened.The device inspection performed by an arjo technician revealed that the carevo side supports can be locked and unlocked despite the missing spring brackets (metal clips that protect the locking handles from rubbing off).These parts do not affect the locking of the side supports.The arjo technician was only able to recreate the event in a specific situation.When he accidentally touched one of the side support handles with his thigh, the handle was released and did not return to its locked position.However, the side support was still locked by the other handle.Nevertheless, if he did the same with the second handle (when the first handle was not locked), the side support opened.This scenario was also confirmed by a simulation performed on the production line.The instruction for use (ifu) (04.Ba.08_16) 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, the root cause of the unintentional opening of carevo's side support could not be determined.No defects were found that could have contributed to the event.According to the information received during the course of the investigation, it can be hypothesized that the unintentional opening may have been the result of the side support not locked and not checked to be in locked position.In summary, according to the customer allegation, the side support opened during use which led to the patient¿s fall, so the device did not perform as intended.The device was used for patient hygiene and in that way it played a role in this event.The complaint decided to be reportable due to the patient 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: 19296009
• Report Number: 3007420694-2024-00121
• Device Sequence Number: 17863094
• Product Code: FSA
• UDI-Device Identifier: 05055982787178
• UDI-Public: (01)05055982787178(11)230220
• 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): 06/17/2024

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: BAC1101-01
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/11/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 70 KG