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

Model Number ALS04

Device Problems Electrical /Electronic Property Problem (1198); No Apparent Adverse Event (3189)

Patient Problem Acoustic Shock (1693)

Event Date 09/02/2023

Event Type  malfunction  

Manufacturer Narrative

Investigaition completion is ongoing.A supplemental report will be submitted when investigation is completed.

Event Description

Arjo became aware of the event involving aura pump.When the customer staff plugged the pump in, the pump¿s fuse allegedly blown and flashed.It created a burning marks on the power cable.The pump was not in use by a patient at that time.No injury was reported.The customer alleged that the staff member informed only that was shocked when the pump blew.According to the evaluation of the clinical specialist, sustained shock did not meet the definition of a serious injury.The involved device was swapped out.

Manufacturer Narrative

Before the aura pump was installed at the customer¿s facility, it passed electrical safety checks.The involved device was returned to arjo and inspected.Photographic evidence provided confirmed that the burning marks were visible on the power cable, however the power cable inspection revealed no wires exposed, no failure was identified.The power cord was replaced due to burning marks.The customer stated that the fuse needed replacing.However, the arjo service technician checked fuse, switch and all the wires and cables inside the pump.No faults were found.Thus the customer¿s statement was not confirmed.Based on the inspection results arjo was not able to identify why the customer stated that the fuse had blown and flashed.It is unknown also why the power cable had burning marks.The customer¿s electrician checked the facility¿s electrical system, however, arjo was not informed about the results of the inspection.Fuse is a pump¿s part that is responsible for user and device protection against electrical shock and short circuit.If the fuse blows it means it operates as intended.Based on the above the root cause of the reported flashes and burning marks on the power cable could not be established.When the event occurred, the arjo product was used by the caregiver, and from that perspective, it played a role in the incident, however, no fault was identified during device inspection.The product operated correctly.The device was not used for a patient treatment or diagnosis when the malfunction occurred.Initially, the complaint was decided to be reportable due to the burning marks on the power cable and the assumption that the power cord might have been damaged during use.In the course of the investigation, it turned out that there was no product failure, and no signs of damage inside the pump.Nothing indicated that the power cable could have been damaged.Therefore it is believed that this scenario is not likely to lead to serious injury in the future.

• Brand Name: AURA
• 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: 17841536
• MDR Text Key: 324556879
• Report Number: 3005619970-2023-00022
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 10/26/2023

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: ALS04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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