MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. NIMBUS 3/ DFS3

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Arjohuntleigh have been able to gather little information about the event so far.A fire has started in a patient's room (impossible to know if the patient started it intentionally or not).The patient left the room when the fire started; no injury reported.The facility called the firefighters and the police; the police is investigating the event therefore arjohuntleigh was not allowed to access the room and inspect the device.Additional attempts of contact will be made to gather additional information.Follow up report will be provided upon conclusion of the investigation.

Event Description

On (b)(6) 2015, it was reported to arjohuntleigh that during the night from saturday to sunday, the mattress burnt.

Manufacturer Narrative

(b)(4).On (b)(6) 2015 it was reported to arjohuntleigh that during the night from saturday to sunday, the nimbus 3 mattress burned in a patient's room.The patient was not injured, the patient left the room when the fire started; arjohuntleigh made several attempts to contact the hospital to get additional information about the cause of the fire and all surrounding circumstances.The hospital did not reveal any details however they confirmed that our device did not cause or contributed to the fire in the patient's room.In relation to the risk of fire, our mattress material is flame retardant to bs7175 ((b)(6) standard - flame retardant bedding for bedcovers and sheets ) and we also warn our customers (as per the 'general warning' pages in our instruction for use) of the remaining flammability risks involved in using our product.The product ifu #(b)(6) contains the following: "do not expose the system, especially the mattress, to naked flames, such as cigarettes, etc".We conclude that this failure is solely a result of an event beyond the realm of our control.Our product at the time of the event was functioning as per its intended use and was not a direct cause of the incident, it was simply present and the existing risk mitigations performed as intended.Although nobody was injured as a result of this event, the risk associated to this particular incident is regarded as severe, therefore we considered to be reportable to the competent authorities in abundance of cautions.

• Brand Name: NIMBUS 3/ DFS3
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki 62052 ; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki 62052 ; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore ste 308; san antonio , TX 78247
• MDR Report Key: 5015525
• MDR Text Key: 23716264
• Report Number: 3007420694-2015-00160
• 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,consum
• Type of Report: Followup
• Report Date: 10/28/2015,08/03/2015

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?: No
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2015
• Distributor Facility Aware Date: 08/03/2015
• Device Age: 16 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/1999
• 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