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

Model Number 636002FR

Device Problem Deflation Problem (1149)

Patient Problem Ulcer (2274)

Event Date 02/21/2022

Event Type  malfunction  

Event Description

Following the information provided the patient was placed on the deflated mattress.Additionally the autofirm function was not working.The bariatric patient allegedly sustained a sacrum bedsore as a result of staying on the deflated surface.The evaluation of device revealed that the cell was punctured.Further information is being collected.

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 patient was laying on the deflated mattress.Additionally the autofirm function was allegedly not working.The bariatric patient sustained a sacrum bedsore allegedly as a result of staying on the deflated surface.The stage of pressure injury is unknown.It is unknown why the patient was left on not inflated mattress.

Manufacturer Narrative

Based on the provided information the root cause of the complained outcome cannot be determined.The evaluation of the device allowed to determine that only one of the cells was punctured for an unknown reason.However, it cannot be determined whether the cell was damaged during use of the device or after it was taken out of use.The technician repaired the device by replacing the defective cell.The device is equipped with the low pressure alarms which indicate air leak in case of e.G.Damage of the cells.Also puncture of the cell does not cause rapid deflation.Therefore, it is considered not likely that one punctured cell could lead to a serious injury.The inspection also revealed that the autofirm function, that the customer claimed to be defective, worked as intended.The autofirm mode can be used to ease the nursing care activities.Once activated, it lasts for 15 minutes and after that time the device goes back to previous pressure settings, if the duration time is not extended manually.The autofirm mode can be extended for next 5 minutes up to 3 times.It is likely that the caregivers might not have been familiar with the proper functionality of autofirm function.The instructions for use for auralis (04.Ai.00en rev.3) includes the following information related to the complained event: "the autofirm mode inflates the auralis mattress to a temporary firm surface allowing the nursing procedures to be performed.The autofirm mode lasts for 15 minutes but may be increased in 5 minute steps to a maximum of 30 minutes." "the low pressure indicator is shown within 30 minutes if the auralis pump detects low pressure within the auralis mattress (.).There is a single warning tone." "perform a full functionality test on the auralis system" - this is a maintenance activity to be performed before every use or every week (if for long term use) by the caregiver.Arjo device failed to meet its performance specification since the cell was punctured.The device was used for a patient treatment.This complaint has been deemed reportable in abundance of caution due to allegation of pressure injury of unknown stage.It is considered unlikely that the alleged autofirm function ¿not working¿ or one cell being punctured could result in a serious injury or death of the patient in the future.Arjo has not recorded such cases in the past.The relation between arjo device and the patient outcome has not been established.

• 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
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 13860827
• MDR Text Key: 288200328
• Report Number: 3005619970-2022-00004
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05056341675501
• UDI-Public: (01)05056341675501(11)20190801
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 636002FR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2020
• 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