MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 152010DAR

Device Problems Fire (1245); Use of Device Problem (1670)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 05/30/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjohuntleigh, a branch of (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted.Additional information will be provided upon the conclusion of investigation.

Event Description

On (b)(6) 2017 arjohuntleigh has been initially notified about the incident involving nimbus 3.In the complaint at hand it was reported that the patient being treated on nimbus 3 mattress passed away due to burns and smoke inhalation.Moreover it was emphasized by the (b)(6) that the cause of the fire was due to a match or cigarette coming into contact with the non-fire retardant bedding.It was also considered likely that magazines and matches that were on the patient's bed contributed to the speed and intensity of the fire.The fire and rescue service also conducted a number of controlled tests concluding that in some of the tests zerobase emollient cream, used by the patient, was impregnated onto the bedding and caused the fire to develop at greater speed.No corelation between arjohuntleigh device and the event occurrence was found.

Manufacturer Narrative

An investigation was carried out into this complaint.On (b)(6) 2017 arjohuntleigh received an information regarding an event which occurred on (b)(6) 2015.It was reported that a homecare bedridden patient receiving a therapy with the use of nimbus system was involved in a fire which resulted in patient's death.According to the information provided to arjohuntleigh, the patient was a heavy smoker, becoming increasingly immobile due to a number of health issues, bedbound since march 2015.The patient had a history of psoriasis which was treated daily with the use of zerobase emollient cream.The patient had smoked in bed despite being repeatedly advised of the fire hazards by health care professionals and various members of her family.The property had a fire alarm system which was connected to a care alert facility and linked to a 24-hour monitoring system.On (b)(6) 2015 (an early morning at 4:10 am) a smoke detector in patient's home was activated.Dispatched fire officers found the patient dead, laid on her bed.When reviewing similar reportable events, we have found (b)(4) other cases presenting a scenario of a mattress being damaged by naked flames.Previously reported events regarded an intentional propagation of the fire or an accidental fire initiation due to smoking in bed.The occurrence rate for this failure mode is currently considered to be very low.This report is currently considered as an isolated case presenting the outcome of patient's death.Following the evidences gathered, there had been a rapidly developing fire (being in a decay stage when found) localized in and around patient's bed.According to west yorkshire fire and rescue service, "the fire was initiated due to a match or cigarette coming into contact with a non-fire retardant bedding".It was also considered likely that magazines and matches that were on the patient's bed have contributed to the speed and intensity of the fire.The fire and rescue service also conducted a number of controlled tests concluding that zerobase emollient cream impregnated onto the bedding caused the fire to develop at greater speed.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.Arjohuntleigh believes that current risk mitigation factors such as device design by use of retardant materials (tested according to bs7175 -british standard - flame retardant bedding for bedcovers and sheets) as well as the product labelling (with currently existing cautionary text in the instruction for use) seem to be accurate.Following the instruction for use #151996-en (nimbus 3) and #649933en (nimbus 4, nimbus professional): "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." although arjohuntleigh nimbus system was involved in the reported incident of fire developed due to smoking in bed, the investigation performed on the knowledge gathered to date did not reveal any potential system malfunctions.It was established that 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 the unfortunate incident which was reported.Nevertheless, an air leakage which might have occurred in the mattress due to its exposure to naked flames may have increased the intensity of an already significantly developed fire.Arjohuntleigh is reporting this incident due to a critical patient's outcome.

• Brand Name: NIMBUS 3 / DFS3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton, regis, bedfordshire, LU5 5 XF; UK LU5 5XF
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton, regis, bedfordshire, LU5 5 XF; UK LU5 5XF
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6812765
• MDR Text Key: 83365006
• Report Number: 3007420694-2017-00178
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

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?: Yes
• Device Operator: Other Caregivers
• Device Model Number: 152010DAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2017
• Event Location: Home
• Date Report to Manufacturer: 09/22/2017
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 09/22/2017
• 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; Other
• Patient Age: 74 YR