MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number PXB001DAR

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out for this complaint with the following conclusions: due to the lack of information about the exact circumstances of this event, arjo was left to review the limited information received per our best efforts, and compare it to our product knowledge.Arjo was informed that a psychiatric patient set fire deliberately to their room.As per information provided by arjo quality director for (b)(6) market, the patient did not sustained any injury.The provided information was not clear but as per arjo quality director the fire could start in the bed sheet and further propagated to the mattress.There was not report of product malfunction prior or during rental phase.As a consequence of the fire, the device was completely burned.Arjo auto logic - dartex mattress are produced with fire retardant materials.The related mattress counts with a reliant is2 removable top cover compliances fire retardant tests (bs7175 0, 1 & 5).The above information is provided to the customer in the device instruction for use, document 630933en_08 · 01/2019.The instruction for use additionally contains a list of precautions, which should be taken into account for user and device safety.The document states that device should not be exposed, especially the mattress, to naked flames, such as cigarettes, etc.Furthermore, it warns that in the event of a fire, a leak in the seat or mattress could propagate the fire.Post market surveillance for auto logic system revealed no additional customer complaints related to the current investigated event.In conclusion, arjo found that the auto logic mattress played a role in this event as most likely it was used for patient treatment.Fire most likely propagated from the bed sheet to the mattress, causing the mattress to burn completely.No malfunction of system prior or during this event was reported.Arjo determined that this event result was caused by a use error as a psychiatric patient deliberately set fire to their mattress.Arjo found this event reportable to the competent authorities in abundance of caution despite patient did not sustain serious injury during this event as the patient set fire to the device what could cause death or serious injury if reoccurs.

Event Description

It was reported to arjo that a psychiatric patient deliberately set fire to their room, burning among other the arjo auto logic mattress.This event occurred during the rental phase of the device.Arjo quality director for (b)(6) market reported the following information: patient was not injured during this event.The information was not clear but the fire could start in the bed sheet and further propagated to the mattress.No product malfunction was reported.It was reported that customer was not able to provide additional information about this incident.As a consequence of the fire, the product was completely burned.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 9075139
• MDR Text Key: 158794113
• Report Number: 3005619970-2019-00015
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PXB001DAR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2011
• 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