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

Model Number ALS01

Device Problem Sparking (2595)

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

Event Date 03/16/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

Arjo was informed that the patient observed spark and smoke coming from the aura pump.The pump was in use by the patient when the problem occurred.No injury was reported.The pump was taken out of use and inspected.No faults were found.

Manufacturer Narrative

The involved device was taken out of use and inspected.It revealed no failure.Thus there is no evidence to believe that the arjo product could cause spark and smoke emission.Based on the inspection results the patient¿s statement could not be confirmed.It is unknown from which device the alleged spark and smoke were emitted.In the course of investigation we learned that the pump was working as intended.Thus the patient¿s statement that the arjo device caused spark and smoke emission was not confirmed.The complaint was assessed as reportable due to the allegation that the patient observed spark and smoke coming from the aura pump.It was however not confirmed that the alleged spark and smoke was emitted by 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: 19094712
• MDR Text Key: 340693489
• Report Number: 3005619970-2024-00012
• Device Sequence Number: 1
• Product Code: FNM
• 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,Followup
• Report Date: 05/10/2024

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 Operator: Health Professional
• Device Model Number: ALS01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2024
• 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