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

Model Number 636003

Device Problems Use of Device Problem (1670); 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 follow-up report will be provide, when the final conclusions will be 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.

Manufacturer Narrative

The skin iq and the therakair visio mattress replacement system help address moisture management and skin microclimate.Low air loss system relates to a property of support surface that allows air to escape from the cells to aid management of skin temperature and moisture (international review.Pressure ulcer prevention: pressure, shear, friction and microclimate in context.A consensus document.London: wounds international, 2010).The auralis, on the other hand, is an alternating pressure mattress system, and does not provide a low air loss therapy.Pressure ulcers are complex, however available literature guides through understanding of the formation of pressure ulcer, e.G.The paper "international review.Pressure ulcer prevention: pressure, shear, friction and microclimate in context.A consensus document.London: wounds international, 2010", stated to: "provide a support surface that is properly matched to the individual's needs for pressure redistribution, shear reduction, and microclimate control¿.- "management of microclimate is one component of pressure ulcer prevention and needs to take place within the context of a comprehensive pressure ulcer prevention protocol that takes into account patient comfort." taking into account all the information gathered, it has been concluded that insufficient knowledge of different support surface properties and insufficient skin care in terms of microclimate management could have been a factor in developing a pressure injury.In summary, the arjo product was involved in the event because it was used to care for a patient when a patient had sustained a serious injury, however, the system met its performance specifications.The system was working properly and the serious injury to the patient was the result of insufficient management of the patient's skin care, not related to arjo product performance.Arjo took a conservative approach and reported this event, solely, due to indication of serious injury sustained by a patient while using arjo product.

Event Description

A customer called stating that the patient who was placed on auralis system (pump and mattress ) 5 days before the call, had developed a pressure injury to the sacrum and coccyx.The injury on the coccyx was a stage iii pressure injury.During an interview with this customer, arjo learned that the patient was switched from an arjo therakair visio mattress replacement system, which is a low air loss therapy system to arjo auralis, which is an alternating pressure mattress system.Patient was left on the auralis mattress surface without linen and an arjo skin iq (microclimate management mattress cover, that was not ordered by the customer).Additional information was that it has been very hot in vancouver for the last 5 days.After the event, the patient was switched back to therakair visio.The auralis pump and mattress were evaluated by an arjo service technician and no fault was detected.System was operating properly.

• 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
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15292997
• MDR Text Key: 298578745
• Report Number: 3005619970-2022-00017
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05056341676997
• UDI-Public: (01)05056341676997(11)200415
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

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
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention