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

Model Number 412001ADV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Breakdown (2681)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer reported that middle section of the mattress had low pressure and that there was a skin breakdown as a result.Arjo technician who checked the mattress found no issue.It was noticed that when the bed frame had knee and backrest section raised, the flow in the mattress might be restricted.

Manufacturer Narrative

Fields f3-5 have been updated.The investigation is ongoing, as soon as the conclusion is available, the follow-up report will be provided.

Manufacturer Narrative

An investigation has been carried out onto this incident and conclusions are following.Arjo was informed about a skin breakdown developed by a female patient (age 80 and weight 77kg) who was placed on a nimbus 3 mattress.It was reported that the central cells of the mattress did not maintain the air.The severity of skin injuries could not have been assessed - despite several attempts made by arjo personnel, no further details could have been obtained from the customer.According to the last information about patient's outcomes, buttocks injury was healed and the heel injury was slowly improving - it was being treated with prescribed dressings under tissue viability nurse attention.The mattress was installed on a days profiling bed.Following the complaint details, additional information about the bed specification remained unknown, however, it may be concluded that the bed had different movable sections, including foot and head ones.Upon the device evaluation made by arjo service engineer the system was found working with no functional problems (both, pump and mattress).The patient has already been removed from the mattress.No source of air leakage was identified.Thus, the device was not taken out of use after the inspection.It was noticed that the head and foot sections of the bed were raised, probably causing a flow restriction issue in mattress cells.The nimbus 3 system instruction for use, document (b)(4), informs about the safe way of using the device and states that this system "represents one aspect of a pressure ulcer management strategy", therefore, it should be "combined with an individualized monitoring, repositioning and wound care program" in order to provide a desired, overall therapy for pressure ulcers.In case of product failure, the nimbus 3 system is equipped with a range of designed alarms which allow to detect a decreasing of pressure in mattress cells.In such cases, a visible indicator on the pump is launched and an audible alarm will inform about the issue.In conclusion, nimbus 3 system (both mattress and pump) was used while the event occurred, therefore, it played a role in the event.The reported malfunction was not confirmed as the system (pump and mattress) was found working without problems.It was not possible to assess the severity of wounds.However, they were not found to be directly related to any malfunction of the device.The exact root cause of the reported event could not have been confirmed.Arjo is reporting this incident in an abundance of caution based on the allegation of skin breakdown of unknown outcome and unclear circumstances of the event.

• 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 hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• MDR Report Key: 8404467
• MDR Text Key: 142092254
• Report Number: 3007420694-2019-00040
• 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,Followup
• Report Date: 05/01/2019

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: 412001ADV
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2019
• Distributor Facility Aware Date: 02/07/2019
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/01/2019
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 02/07/2019; 02/07/2019
• Supplement Dates FDA Received: 04/03/2019; 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 77