MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 151002

Device Problems Deflation Problem (1149); Decrease in Pressure (1490); No Pressure (2994)

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

On (b)(6) 2019, arjo was notified about a complaint involving the nimbus 3 air pressure mattress.It was informed that the mattress had completed deflated during the weekend (on (b)(6) april).The patient had to sleep in a wheelchair.The customer advised that some pressure injuries were developed over the weekend.

Manufacturer Narrative

Arjo has carried out an investigation to this incident, and the conclusion are the following.Arjo was informed about a customer complaint that relates the deflation of a nimbus 3 mattress.It was reported to arjo that the mattress deflated and in a consequence the patient was left in a wheelchair during the weekend before the customer called arjo.Patient's wife (complainant) advised that some pressure injuries were developed over the weekend.However, due to the australian privacy act, arjo could not determine how, when, or if the reported pressure injury occurred because of the mattress system.Arjo technician attended on site the following day after the incident was reported, customer's mattress and pump were taken away to be tested, and the customer was supplied with a loaner nimbus 3 system (mattress and pump).Arjo technician confirmed that the pump was alarming due to the low pressure in the mattress.The last service order before the incident was dated in january 2019, 3 months before this event.In this service, the manifold assembly was replaced due to a slow deflation of the mattress.The mattress was repaired and left in working condition.Nimbus 3 system (mattress and pump) was setup, tested and found a connection not connected appropriately (internal manifold assembly).The system was reconnected and tested, and everything was working.The visual condition of both mattress and pump were found serviceable.Nimbus 3 system is an air mattress indicated for the prevention and management of all categories of pressure injuries when combined with proper monitoring, reposition and wound care program.Low pressure is usually a result of air leakage within the pump or mattress assembly or insufficient air supply.In these cases, the device counts with a visual indicator and a build alarm intended to inform whenever the pump detects low pressure within the mattress.Post market surveillance was reviewed, no reportable complaints related to the disconnection of the manifold assembly tube from the nimbus system were found.In conclusion, a disconnected manifold of the mattress caused a deflating issue within nimbus 3 mattress.It is unknown the causes of the disconnection since the mattress was serviced 3 months before this incident, and left repaired and in working condition.It is unknown the severity of the injury and how, when, or if the reported pressure injury occurred because of the mattress system.However, arjo reported this event to the competent authority based on the assumption that leaving the patient on a wheelchair might contribute to an injury.

• Brand Name: NIMBUS 3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton; houghton hall business park; houghton regis, LU5 5 XF; UK LU5 5XF
• MDR Report Key: 8585959
• MDR Text Key: 147322849
• Report Number: 3005619970-2019-00006
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

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: No Information
• Device Model Number: 151002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2019
• Distributor Facility Aware Date: 04/08/2019
• Event Location: Home
• Date Report to Manufacturer: 06/06/2019
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 04/08/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other