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

Model Number 636001

Device Problem Sparking (2595)

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

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

The auralis instruction for use (ifu) (b)(4) dated 10/2022 includes guidance and warning in regards to the power cable.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".In the complaint at hand, the user was aware the issue, excluded device from use and requested service.To sum up, the root cause of the sparks coming from the power cord is related with the damaged power cable which was not secured using the cable management system.Arjo device failed to meet its performance specification since the power cord was damaged.When the event occurred, the arjohuntleigh product directly involved with 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.

Event Description

Arjo became aware of the event involving the auralis pump.The mains lead of the pump got trapped between the safety side locking mechanism when customer¿s staff raised it.It resulted in sparks.The device was swapped out.No injury was reported.

• 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: 17697172
• MDR Text Key: 322813806
• Report Number: 3005619970-2023-00018
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05056341675235
• UDI-Public: (01)05056341675235(11)221108
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 636001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• 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