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

Model Number 151013

Device Problem Decrease in Pressure (1490)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2016 arjohuntleigh received a customer complaint where it was indicated that the mattress not stay inflated.It was reported that the staff pumped it up many times and mattress does not keep the air.They wanted to fix or replace the equipment as the patient involved has severe skin breakdown.

Manufacturer Narrative

An investigation was carried out into the complaint.Based on the information received it appears most that the nimbus 3 / dfs3 mattress could not stay inflated due to a slight tear on the bottom seal in the main cell.It was indicated to us that the mattress should be replaced or fixed as the patient has severe skin breakdown.Review of reportable complaints for nimbus system showed that there are no similar events.Therefore, the incident described above seems to be an isolated event to date.It cannot be clearly established if the nimbus system was being used for patient care when the event took place due to very limited information received.No malfunctions were reported regarding the nimbus pump involved but the mattress was found with a slight tear on the bottom seal in the main cell.Following the above it can be established that the nimbus system was found to have malfunctioned (not to specification) when the event took place.The limited information and lack of possibility to gather more details unfortunately does not allow us to establish the root cause of this failure: we could not establish why there was a slight tear in the mattress.However there is no indication that the pump alarm function has malfunctioned.The pump low pressure alarm activates when the pressure the in mattress cells will drop to the certain level (of 10 mmhg).When there is a low pressure state in the system, the pump needs to detect 3 consecutive cycles of low pressure to activate the alarm.With a 10 minutes cycle, the alarm is triggered after approximately 30 minutes.Therefore, it appears that if the mattress was used in this state with a patient, the alarm in the pump had sounded after 30 minutes, the issue with low pressure in the mattress would have been detected and an appropriate action to move the patient on to another mattress could have been taken.This would have mitigated the potential risk of any hazardous situation.Consequently to the above, we come to the conclusion that it appears highly unlikely that the mattress malfunction contributed to the patient's injury reported "severe skin breakdown" while the device is used as intended and the patient is monitored as it is described in the nimbus instruction for use (ifu).This is shown by the absence of complaints volume with similar scenario when compared to the amount of sold devices and in comparison to their daily use.Our investigations shows there appears to be no clear link between the use of the device with the malfunction and the reported outcome of event, as described.Nevertheless, due to very limited information received regarding the circumstances of the event, we decided to report this event to competent authorities in the abundance of caution.

Event Description

On 07 june 2016 additionally it was indicated by the rental technician that: "the issue we found with the dfs3 mattress (b)(4) was one of the main cells had a slight tear on the bottom seal.We replaced the cell and the mattress passed qc.".

• 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: 5551055
• MDR Text Key: 41984157
• Report Number: 3007420694-2016-00045
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/13/2016,03/07/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 151013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2016
• Distributor Facility Aware Date: 03/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2016
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2016
• 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): Other