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

Device Problem Fire (1245)

Patient Problem Death (1802)

Event Date 11/01/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo was notified about an incident involving nimbus system.The exact model number and serial number was not provided.It was reported by (b)(6) fire and rescue service that there was a fatal fire and the deceased was sleeping on what was believed to be a nimbus air mattress.Currently, there is no indication that arjo mattress could contribute to the issue.Investigation by fire and rescue service is ongoing.

Manufacturer Narrative

Collecting information ongoing.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

Arjo was notified about an incident involving nimbus system.The exact model number and serial number was not provided.It was reported by (b)(6) that there was a fatal fire and the patient was sleeping on what was believed to be a nimbus air mattress.As the fire service during inspection notice that brand name "nimbus" was visible on remains of pump.The equipment has been isolated.Arjo had no access to confirmed any details.Currently, there was no indication that arjo mattress could contribute to the issue.Investigation by fire and rescue service is ongoing.No additional information was provided to this date.Nimbus mattresses comprise of air-inflated, alternating pressure cells dedicated for prevention and management of pressure ulcers.Top covers of nimbus mattresses are made of a pu coated fabric which is fire retardant material tested in accordance with applicable standards.Please note that mattresses base covers has been tested according to bs7175 - (b)(4) standard - flame retardant bedding for bedcovers and sheets and passed this test with positive result.Following the instruction for use #151996: "do not expose the system, especially the mattress, to naked flames, such as cigarettes, etc"."in the event of a fire, a leak in the seat or mattress could propagate the fire." from arjo review it was concluded that there the product is not violative in any way.The material of nimbus top cover is conforming to applicable standards and is not considered to have contributed to the outcome of this unfortunate incident which was reported.To sum up there was limited information related to event circumstances.The nimbus system played a role in the incident as it is believed that the patient was sleeping on the mattress.If the investigation results (conducted by fire and rescue service) will be shared and give new light into the investigation or root cause, the follow up report with new conclusion will be sent to authorities.Complaint decided to be reportable due to a critical patient's outcome.

• Brand Name: NIMBUS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• Manufacturer (Section G): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 8163880
• MDR Text Key: 130318830
• Report Number: 3005619970-2018-00020
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2019

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 Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2019
• Distributor Facility Aware Date: 11/22/2018
• Date Report to Manufacturer: 01/25/2019
• Initial Date Manufacturer Received: 11/22/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 11/22/2018; 11/22/2018
• Supplement Dates FDA Received: 01/11/2019; 01/30/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death