MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O. O. NIMBUS 3 / DFS3; FNM

Model Number 152010DAR

Device Problems Thermal Decomposition of Device (1071); Human Factors Issue (2948)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event not because there was a technical malfunction of the device, but since due to a use error, the device did not perform as intended.An investigation was carried out into this complaint.Following the information received, it appears that during the night, the nimbus 3 mattress burned in a patient's room.The patient was not injured.When reviewing similar reportable events, we have found a number of cases with similar fault description (the mattress system damaged by naked flames or cigarettes).The occurrence rate observed for reportable complaints with this failure mode is currently considered to be very low.The circumstances of the incident indicate a use error.According to the information collected "aggressive alcoholic and drugged" patient set his mattress on fire.Based on the information received neither the mattress nor the pump was a source of fire.Photographic evidence provided confirmed very severe damage to the mattress.From the picture provided we are unable to see the condition of the pump, however following the information collected the pump was intact.In relation to the risk of fire, our mattress material is flame retardant to (b)(4) ((b)(4) standard flame retardant bedding for bedcovers and sheets ) and we also warn our customers (as per the 'general warning' pages in the instruction for use for nimbus 3) of the remaining flammability risks involved in using our product.The product ifu #(b)(4) contains the following: "do not expose the system, especially the mattress, to naked flames, such as cigarettes, etc." based on the information gathered and our investigation performed it can be concluded that the issue reported 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 this complaint to be reportable to the competent authorities in abundance of caution.

Event Description

On 4 may 2016 arjohuntleigh received a customer complaint where it was indicated that the patient set his mattress on fire during the night.According to the information collected "aggressive, alcoholic and drugged" patient burnt his constraints and the nimbus 3 mattress.The patient was not injured as a result of this incident.

• Brand Name: NIMBUS 3 / DFS3
• Type of Device: FNM
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O. O.; ks. piotra wawrzyniaka 2; komorniki, PL62- 052; PL PL62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O. O.; ks. piotra wawrzyniaka 2; komorniki, PL62- 052; PL PL62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore,; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5696969
• MDR Text Key: 46495393
• Report Number: 3007420694-2016-00100
• 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: company representative,health
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/03/2016,05/04/2016

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: Lay User/Patient
• Device Model Number: 152010DAR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2016
• Distributor Facility Aware Date: 05/04/2016
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2016
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2009
• 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