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

Model Number 636B02

Device Problem Deflation Problem (1149)

Patient Problem Ulcer (2274)

Event Date 11/29/2021

Event Type  Injury  

Event Description

Following the information the customer noticed that the air mattress was almost completely deflated.At that time the patient was on the mattress, who had a sacred bedsore, having tunnelled about 25 cm.The patient sustained back pain because of being placed on the deflated surface.As per the customer's technician, the mattress "had to be drilled/punctured".The customer stated that as a result of the deflation, the patient's sacral area wound condition worsened.

• 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: 13024462
• MDR Text Key: 282384213
• Report Number: 1419652-2021-00049
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 636B02
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2021
• Distributor Facility Aware Date: 12/07/2021
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female