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

The arjo system that was destroyed in the fire was mattress sn (b)(6) and pump (b)(6).

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 suspicious is that the patient was smoking in the bed.There is no allegation of arjo product malfunction.The arjo device was destroyed in the fire.The arjo system that was destroyed in the fire was mattress sn (b)(6) and pump (b)(6).

• 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
• MDR Report Key: 17264231
• MDR Text Key: 318437211
• Report Number: 1419652-2023-00044
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: AT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 630004DE
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2023
• Distributor Facility Aware Date: 06/09/2023
• Event Location: Other
• Date Report to Manufacturer: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death