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

Model Number 636002DE

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 09/12/2022

Event Type  Injury  

Event Description

According to the initial information provided to arjo, there was a patient with wound healing problems or skin injury while using auralis mattress.Arjo representative followed up with the customer and was able to establish that over night the compressor got amber light, mattress fully filled hard, and it was not possible to change pressure settings.The staff was not able to set the auralis back to alternating therapy mode.The pump was taken out of use and returned for investigation.As per the information provided the patient sustained stage 3-4 sacral decubitus, which was assessed by arjo clinical specialist as a serious injury.The results of evaluation are not known at the time of submission of this report.

Manufacturer Narrative

The investigation is in progress.The information was passed to the manufacturer.The conclusions will be provided within the manufacturer's follow-up report 3005619970-2022-00021 once the investigation is completed.

• Brand Name: AURALIS PUMP
• 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: 15585614
• MDR Text Key: 301555886
• Report Number: 1419652-2022-00043
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 636002DE
• 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: 10/12/2022
• Distributor Facility Aware Date: 09/14/2022
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 60 KG