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

Model Number 152001

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

On (b)(4) 2014, it was reported to arjohuntleigh that the product - nimbus 2 mattress, was burned while being rented.The pt had deliberately set his room one fire.There was no allegation of malfunction.Nobody was injured as a result of this incident.

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type event not because there was a technical malfunction of the device, but since due to a use error the device was damaged.On (b)(4) 2014 arjohuntleigh was notified that one of our products - nimbus 2 mattress, allegedly had caught fire.The local arjohuntleigh sales and service unit rep was nominated to visit the facility to obtain comprehensive info about the incident.During interview with the nurse, we have been informed that the "psychiatric" pt deliberately set fire to his room.Fortunately nobody was injured as a result of this incident.Furthermore it was confirmed that neither mattress nor the pump was the source of the fire.Photographic evidences provided confirm very severe damage to the mattress.From the pictures also we can see that the pump was intact.In relation to the risk of fire, our mattress material is flame retardant to (b)(4) 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#152997en-01 contain the following: safety: "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.Furthermore it was also noted that at the time of the incident the device was not used either for treatment or diagnosis.

• Brand Name: NIMBUS 3 / DFS3
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4477451
• MDR Text Key: 5400494
• Report Number: 3007420694-2015-00015
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/17/2014

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: Other
• Device Model Number: 152001
• 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: 01/16/2015
• Distributor Facility Aware Date: 12/17/2014
• Device Age: 13 NA
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2015
• Initial Date Manufacturer Received: 12/17/2014
• Initial Date FDA Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2002
• 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