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

Model Number 636001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Deflation (4061)

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

Event Date 07/19/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

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 sarcumischium and buttocks; moisture lesion to natal cleft and coccyx; purple/black intact skin buttocks.

Manufacturer Narrative

The pressure ulcers are complex.The paper "international review.Pressure ulcer prevention: pressure, shear, friction and microclimate in context.A consensus document.London: wounds international, 2010" explains what pressure is, how pressure contributes to pressure ulcer formation and how to identify patients at risk of injury from pressure (including usage of scoring tools as a support of assessment as was done by the caregivers).Those information are spreaded throughout the paper.This paper stated to: "provide a support surface that is properly matched to the individual's needs for pressure redistribution, shear reduction, and microclimate control.The notes taken by the caregivers and risk assessment show that the patient's condition was constantly monitored.The patient was moved from a foam mattress to the auralis alternating therapy system as soon as the need was determined (blanching was observed).Based on the collected information it was established that the root cause of the complained pressure injury sustained by the patient was not related with the arjo auralis system, but rather with the patient's health condition.The evaluation of the mattress and the pump performed after the devices were returned to arjo service center did not reveal any malfunctions, hence the alleged deflation was not recreated.In addition, the customer admitted that the mattress was working correctly and inflating later the same day that the deflation issue was raised.Arjo system was used for a patient treatment when the patient developed serious pressure injury and from that perspective it played role in the event.Customer alleged that the mattress deflated, however the system (mattress and pump) evaluation did not reveal a defect.The customer allegation could not be confirmed.This complaint is deemed reportable in abundance of caution due to allegation of pressure injury, which may indicate serious injury, sustained during use of arjo device.

Event Description

Following the initial information provided the mattress allegedly deflated when the patient was placed on it.The patient sustained a pressure injury.Upon admission to the hospital on (b)(6) 2022, the patient was assessed as being at very high risk of pressure injury development according to waterlow scoring (26 points).According to the chronological information gathered by arjo representative from the customer's employee, the history of the patient's condition is the following: (b)(6) 2022: blanching inner buttocks was observed, the patient was catheterised (suprapubic), waterlow score at that time was 27 (still very high risk of pressure injury development).(b)(6) 2022: the patient has been placed on air mattress (auralis) - prior to this date the patient was on an unknown foam mattress.(b)(6) 2022: detected blanching (category 1) to sacrum, ischium and buttocks (assessed by arjo clinical specialist as minor injury); moisture lesion to natal cleft anc coccyx (also assessed by arjo clinical specialist as minor injury) and purple/black intact skin buttocks (with an abundance of caution assessed by arjo clinical specialist as serious injury, as it may be a deep tissue injury).The auralis system was working up to the specification throughout this time period.(b)(6) 2022: blister to left buttock was observed.It was noted that the mattress allegedly deflated during night and again that morning.

• 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: 15222547
• MDR Text Key: 297859525
• Report Number: 3005619970-2022-00015
• 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: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

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
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 94 KG