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

Model Number 630004DE

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 05/30/2023

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.It is suspected that smoking in the bed could be the cause of the fire.When conclusion is available, the final report will be submitted.H3 other text : destroyed in fire.

Event Description

Arjo was notified about a fire in the hospital and a patient death while being on arjo mattress when the fire occured.The initial suspicious is that the patient was smoking in the bed.There is no allegation of arjo product malfunction.The investigation in ongoing.The arjo system that was destroyed in the fire was mattress sn: (b)(6) and pump sn: (b)(6).

Manufacturer Narrative

The autologic system was destroyed in a fire at a hospital.A fire spread to a four-bed room.Three patients died.A patient who was assumingly smoking a cigarette died while using the arjo system.Available information indicates that the fire started from the bed.This event is under prosecution investigation.Details have not been disclosed to arjo, however, there are no allegations against the arjo system.Due to the lack of information on the exact circumstances of the event, arjo was left to review the limited information received.An article in the austrian press 'heute', which describes the incident, indicates that the trigger of the fire was a 75-year-old patient's cigarette.No malfunction of the arjo product was reported.Arjo auto logic mattress covers are manufactured from fire ¿ retardant materials.The cover complies with the flammability standards bs7175 0, 1 and 5.The above information is communicated to the customer in the device instruction for use (630933en).The instruction for use additionally contains a list of precautions, which should be taken into account for user and device safety.The document states that device should not be exposed, especially the mattress, to naked flames, such as cigarettes, etc.Furthermore, it warns that in the event of a fire, a leak in the seat or mattress could propagate the fire.The auto logic mattress was used for patient treatment when the fire started, however, the mattress did not fail to meet its specification.The cause of the fire is most likely related to a patient smoking on the bed.Arjo decided to report the incident, taking a conservative approach, as the patient who smoked the cigarette was lying on the arjo mattress and died as a result of the fire.

• Brand Name: AUTO LOGIC
• 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: 17264227
• MDR Text Key: 318438205
• Report Number: 3005619970-2023-00016
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 630004DE
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death