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

Model Number 636003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 07/24/2022

Event Type  Injury  

Manufacturer Narrative

The conclusions will be provided wihin the manufacturer's follow-up report, once available.

Event Description

The patient developed a pressure injury to sacrum and coccyx.The stage of pressure injury on the coccyx was a stage iii.As per the information provided the customer ordered an auralis for the patient.The patient was placed on the auralis mattress replacement system for approximately 5 days.The arjo representative determined that the other nswoc (nurse specialized in wound, ostomy and continence) had incorrectly instructed staff to not use linen and to place patient directly on the auralis cover.The auralis pump and mattress were evaluated by arjo service technician and no fault was detected.

• 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
• MDR Report Key: 15292995
• MDR Text Key: 298578670
• Report Number: 1419652-2022-00037
• 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: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/25/2022

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
• Device Operator: Health Professional
• Device Model Number: 636003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2022
• Distributor Facility Aware Date: 07/28/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other