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

Model Number 636001

Device Problem Unintended Deflation (4061)

Patient Problems Skin Discoloration (2074); Blister (4537); Localized Skin Lesion (4542)

Event Date 07/19/2022

Event Type  Injury  

Event Description

Following the information provided the mattress deflated when the patient was placed on it.The patient sustained a pressure injury.The nursing staff found a blister to the patient's buttock the same day.The following outcomes to the patient were found upon the assessment: category 1 blanching to sarcum ischium and buttocks; moisture lesion to natal cleft and coccyx; purple/black intact skin buttocks.

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the manufacturer's follow-up report (b)(4) once the investigation is completed.

• 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: 15222546
• MDR Text Key: 297859470
• Report Number: 1419652-2022-00036
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05056341675235
• UDI-Public: (01)05056341675235(11)200613
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 636001
• 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: 08/13/2022
• Distributor Facility Aware Date: 07/19/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 94 KG