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

Model Number ALS04

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 11/21/2021

Event Type  malfunction  

Event Description

On 2 january 2024, arjo was informed by the police about the event involving the arjo product.The event took place on 21 november 2021 and resulted in the electric shock of a caregiver.An arjo employee retrieved the mattress the same day.On 10 january 2024, the police provided the room number where the event occurred.Based on the limited information received, it was established that the aura pump was involved in the event.The customer called the arjo call center on (b)(6) 2021 and reported that the mattress deflated and the pump¿s cable had exposed wires.There was no indication of any injury.The pump was collected from the facility the same day.The device was inspected on 25 november 2024 by an arjo service technician.No parts were replaced.The product went back to the rental circuit.

Manufacturer Narrative

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

Event Description

On 2 january 2024, arjo was informed by the police about the event involving the unknown arjo mattress.The event took place on 21 november 2021 and resulted in the electric shock of a caregiver.The customer stated that the mattress deflated and the power cable had exposed wires.On 10 january 2024, the police provided the room number where the event occurred.This information allowed arjo to establish that the aura pump and aura seat cushion were rented to this room.The customer might state ¿mattress¿ but could referred to aura system.The pump was collected from the facility and inspected by an arjo service technician on 25 november 2021.No parts were replaced.The product went back to the rental circuit.

Manufacturer Narrative

Arjo was informed by the police that the caregiver received an electric shock from unknown arjo's device.In the course of the investigation we learned that customer alleged that the mattress deflated and the power cable had exposed wires.We were able to identify the equipment that was rented to this customer as an aura pump and aura seat cushion.The customer might state ¿mattress¿ but could referred to aura system.The cushion remained with the customer without further issues.The pump returned for further inspection.It revealed no failure.There is therefore no evidence that would indicate that the arjo product could cause the caregiver to receive an electric shock.Based on the above the customer¿s allegation that the caregiver received electric shock due to the exposed wires of damaged power cable from arjo device could not be confirmed.Based on the available documentation, we determined that an arjo aura pump was rented to the room in which the caregiver allegedly received an electric shock.In the course of investigation we learned that the pump was working as intended.Thus the customer¿s allegation that the arjo device malfunctioned and could cause an electric shock was not confirmed.The complaint was assessed as reportable due to the customer allegation that the caregiver got electric shock.It was however not confirmed that the electric shock was from arjo product.

• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 18567269
• MDR Text Key: 333541997
• Report Number: 3005619970-2024-00003
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: ALS04
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2017
• 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