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

Model Number	BAC1111-01
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Arjo was notified about an event with involvement of carevo shower trolley.It was reported that a patient fell out of the device.According to the information reported the patient was being bathed by a nurse and a nursing assistant using the carevo shower trolley.The patient was a male weighing over 100 kg.When they turned him on the side, he was leaning toward the right side support which got released and patient fell down on the floor.There was the nursing assistant standing on the side and the patient slid down on his legs.The patient was caught by the legs of the assistant.No injuries were reported as a consequence of the event.
Additional Manufacturer Narrative
The devive was inspected by an arjo representative.No malfunctions were found.The conclusions will be provided within the follow-up report once the investigation is completed.
Additional Manufacturer Narrative
Arjo was notified of an incident involving a carevo shower trolley.It was reported that a patient fell out of the device.According to the reported information, the patient was being bathed by a nurse and a nursing assistant using the carevo device.When they turned the patient to the side, the patient leaned toward the right side support, which released and the patient fell to the floor.The nurse stood to the side while the patient slid down onto her feet.No injuries were reported as a result of the incident.According to the information received, the carevo was in use after the event and the side support, which had unlocked during the incident, had been put back on and was holding well.An arjo technician visited the customer to check the device.No malfunctions were found and this was also confirmed by the photo evidence provided.There was no need for repair and no other observations were found, nevertheless, the arjo technician decided to replace the side support for preventive reasons only.The carevo is equipped with two side supports to secure the patient.The side support has three positions, presented in the instruction for use (ifu): inner, outer and folded down.The instruction for use provides information that when side panels are raised to a desired position they should lock and click into place.A caregiver should ensure that the side panels 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¿ ¿to avoid the patient from falling out of the device make sure that all side supports are in a locked position.¿ additionally, the ifu concerns details regarding correct patient positioning (together with supporting illustrations): ¿to make sure that the patient cannot slip out through the side support, make sure that the mattress sides are up and not folded underneath the patient.¿ 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 incident.According to the information received, 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's allegation, the side support opened during use which led to the patient¿s fall, so the device did not perform as intended.The technical evaluation did not reveal any malfunction which could contribute to the event.The shower trolley was used for patient hygiene and in that way it played a role in this event.This complaint was decided to be reported to the competent authorities due to an indication of the patient's 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: 15697802
• Report Number: 3007420694-2022-00174
• Device Sequence Number: 12439170
• Product Code: FSA
• UDI-Device Identifier: 05055982787178
• UDI-Public: (01)05055982787178(11)220809
• 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): 11/18/2022

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: Health Professional
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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: Male
• Patient Weight: 100 KG