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

Model Number	636003US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer claimed an increase in pressure injuries for numerous of patients during usage of the auralis systems with skin iq.On 22 oct 2024, arjo became aware of the information that two patients sustained serious pressure sore during usage the auralis system.One of two patients (assessed in the complaint with our internal reference number tw (b)(4) sustained 2 pressure injuries (left ischium and left lateral thigh both deep tissue injuries or dti's) and second patient sustained 3 pressure injuries (assessed in our internal reference number tw (b)(4)-upper occipital non-stageable, lower occipital dti, left ischial stage iv) the facility was contacted to adress the issue.Additional training was provided on how to adjust the pump settings for the patient's comfort.The system was swapped.No system malfunction was found.

• Brand Name: AURALIS
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• MDR Report Key: 20722974
• Report Number: 1419652-2024-00066
• Device Sequence Number: 17788079
• Product Code: FNM
• UDI-Device Identifier: 05056341675259
• UDI-Public: (01)05056341675259(11)240603
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2024
• Report Date (Section F): 11/19/2024

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: 636003US
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/22/2024
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/19/2024