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

Model Number 151013

Device Problems Decrease in Pressure (1490); Unclear Information (4052)

Patient Problem Pressure Sores (2326)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4), a branch of (b)(4) (under registration #(b)(4)).From 2014 and going forward complaints related to these products are to be handled by (b)(4)complaint handling establishment and any medwatch reports will be submitted under registration # (b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

A claim was received allegedly involving arjo mattress.The claim was that the patient was admitted to the hospital - (b)(6) medical center for antibiotic therapy and ongoing treatment needed for a left ischial wound.Due to the location of his wound, the patient was laying on his right side.As reported in the summons the mattress was defective and caused the patient to end up resting directly on the bed frame.As a result, the patient suffered serious skin breakdown on his right side (hip) and required a number of additional surgeries.It was reported that the patient is still in need of additional surgeries for the injury.We have not received information what arjo product was involved in the reported incident.We have checked the historical rental orders from this customer and found out that 5 days after the patient's admission, the hospital ordered nimbus 3 system.Therefore, our best guess is that the nimbus 3 system could have been involved in the event.

Manufacturer Narrative

This event is still investigated.When investigation conclusion is available, a follow-up report will be provided.

Manufacturer Narrative

Investigation has been conducted and results are following.On 17 march 2019 arjo received a claim about a faulty arjo mattress which was allegedly caused by a patient resting directly on the bed frame.As a result patient allegedly sustained serious skin breakdown.As reported in the summons, the patient allegedly suffered serious skin breakdown on his right side (hip) and required a number of additional surgeries.It is alleged that the patient is still in need of additional surgeries for the injury.Based on the summons, the patient was admitted to the hospital (b)(6) medical center on or about (b)(6) 2018 for antibiotic therapy and ongoing treatment needed for a left ischial wound.Allegedly, due to the location of his wound, the patient was laying on his right side.No information was received which arjo product was involved in the event.But upon checking the historical rental orders we found out that 5 days after the patient's admission, on 20 march 2018, the hospital ordered nimbus 3 system.Service records were checked for the involved nimbus 3 product and no information about repair or part replaced was found.The nimbus system was delivered to the customer on 20 march 2018 and picked up on 6 april 2018.It went through quality control check on 24 april 2018.Part of the quality control inspection is to check pressure the pump is generating and to ensure the mattress maintains air correctly.No fault was detected.According to the applicable arjo team service lead who remembered the event, the pump was placed on the floor, and not on the footboard.Because of that placement, the hose connection to the pump was under stress, causing the hose to become partially disconnected.This further resulted in an air leak and mattress deflation.If the pump is to be placed on the floor, the customer needs to ensure that the tubeset is not trapped or placed in a position causing hazard (e.G.Is not kinked, and is placed in a way allowing proper air flow).The applicable product instruction for use 151996en_04 states: - "make sure that the mains power cable and tubeset or air hoses are positioned to avoid causing a trip or other hazard, and are clear of moving bed mechanisms or other possible entrapment areas".Even if the tubeset is not connected properly casing an air leak, the numbus 3 system (which is equipped with an alarms) will sense low pressure in the mattress activating the visual and audible warning.In the complaint at hand, no technical defect was found within the nimbus 3 product.Thus, the pump was operating correctly and alarm should have been detected by caregivers.The nimbus 3 system is indicated for the prevention and management of all categories of pressure ulcer when combined with an individualized monitoring, repositioning and wound care program.As per product ifu "if patients have other unstable fractures, or conditions which may be complicated by a soft or moving surface, advice should be sought from an appropriate clinician before use".In summary, based on the collected information it can be assumed that the nimbus 3 product was used for patient treatment at the time of event, the nimbus 3 system did not perform as intended due to a user error as no technical failure was found after the product returned from the customer.

• 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: 8508373
• MDR Text Key: 141731594
• Report Number: 3007420694-2019-00064
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 151013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2019
• Distributor Facility Aware Date: 03/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2019
• Date Manufacturer Received: 03/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention