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

Model Number 636001

Device Problems Decrease in Pressure (1490); Sparking (2595); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2023

Event Type  malfunction  

Event Description

Arjo became aware of the event involving the auralis system.The customer heard the loud noise and observed sparks from the damaged power cord.The customer claimed also the mattress deflation.The system was not in use by a patient at that time.No injury was reported.

Manufacturer Narrative

The auralis instruction for use (ifu) 04.Ai.00en_03 dated 10/2020 includes guidance and warning in regards to the power cable and power failure.The ifu states that power cord "must be positioned in the cable management on the left side of the auralis mattress".This document describes and provides graphical images showing the cable management and instruction on how the power cord should be positioned using the cable management.The ifu warns "to avoid falling and injury, make sure that cables and the tube-set are positioned correctly and are clear of moving bed mechanisms or other possible entrapment areas".When the power cable is damaged, there will be no power to the pump and at some point in time the mattress may start loosing air.However, according to ifu ¿if there is a power failure, the auralis pump enters battery mode.If the auralis pump is fully charged the auralis pump offers a minimum of 3 hours operational use¿.An allegation of mattress deflation could have been related with the damaged power cord.To sum up, the root cause of the sparks coming from the damaged power cord and loud noise was related with the non-use of cable management system.Arjo device failed to meet its performance specification since the power cord got damaged.When the event occurred, the arjohuntleigh product was directly involved in the reported incident.There is no allegation that the device was used for a patient treatment or diagnosis when the malfunction occurred.This complaint is deemed reportable due to the allegation of sparks emission from the damaged power cord.No injury was sustained.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17841478
• MDR Text Key: 324560540
• Report Number: 3005619970-2023-00021
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05056341675235
• UDI-Public: (01)05056341675235(11)210417
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 636001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2021
• 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