MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. AURALIS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 636M02S

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

Following information gathered, no device problem was found.The facility was aware of the patient rolling out from the bed issue due to historical data therefore they used the matt support and put the bed in the lowest position.The instructions for use for auralis ifu (04.Ai.00en_05 2023/07) warns the user that "if patient is to be left unattended whilst using the device, the risk of falling and injury should be clinically assessed, in line with local policy.".The facility took steps to avoid and minimize the risk of patient fall correctly.It is considered that the fall might have been related to a patient's condition.The arjo device did not fail the specification during the event.The device was used for patient treatment.The complaint was assessed to be reportable due to the allegation that the patient fell from the auralis mattress.

Event Description

Following the information gathered, the patient fell from the auralis mattress.The patient was found on the floor by a staff.According to the facility member statement the patient was small and the bed that was in use had only two top rails.The facility stated that the patient has been rolling off the bed in the past, therefore the bed was put in the lowest position and the mat was placed on the floor to support the patient body.No mattress malfunction was found.No injury was claimed.

• Brand Name: AURALIS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 19123176
• MDR Text Key: 341368529
• Report Number: 3005619970-2024-00013
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2024

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
• Device Operator: Other
• Device Model Number: 636M02S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female