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 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

The auralis instruction for use (ifu) 04.Ai.00en_04 dated 10/2022 states: ¿the power cable 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 instructions on how the power cord should be positioned using the cable management.The customer was aware of the need to use a cable management system.The photographic evidence provided confirms that the system was in use.Apart from using the cable management system, the cable position should be checked to avoid collision with bed moving parts.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".The ifu states: ¿íf any part is damaged or missing do not use the product¿.In the complaint at hand, the user was aware of the issue, excluded device from use and requested service.To sum up, the root cause of the observed sparks was the damage of the pump's power cord.The damage occurred as a result of the power cord being trapped between the moving parts of the bed.According to the ifu it should be checked whether the power cable is positioned correctly and is clear of moving bed mechanisms.Arjo device failed to meet its performance specification since the power cord was damaged.When the event occurred, the arjo product was directly involved in the reported incident.The device was not in use by a patient 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 customer reported that the power cable was damaged when a staff was operating the patient¿s bed.Internal wires were exposed and sparks were observed.The provided photos confirmed that the cable was damaged and the cable management system was in use.The pump was not in use by a patient when the issue occurred.No injury was reported.The pump was repaired by the power cable replacement.

• 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: 19088409
• MDR Text Key: 340693104
• Report Number: 3005619970-2024-00011
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05056341675235
• UDI-Public: (01)05056341675235(11)230107
• Combination Product (y/n): N
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 636001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2023
• 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