MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 151010

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 08/28/2021

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).The investigation is ongoing, no final conclusions are available at this time.

Event Description

On 10 sep 2021 arjo became aware that a patient developed a serious pressure injury at time of use a faulty nimbus 3 system.The patient medical condition included the stage iii-iv pressure injury on the heel which was treated with cream and a porous boot and the infected sacral injury which was treated with medication.

Manufacturer Narrative

On 10 sep 2021 arjo became aware that on (b)(6) 2021 a patient developed a serious pressure injury at time of use a faulty nimbus 3 system.The pressure injuries were stage iii-iv on the heel which was treated with cream and a porous boot and the infected sacral injury which was treated with medication.Based on the collected information, the involved nimbus 3 system was installed by the arjo representative on (b)(6) 2021.The same day ((b)(6) 2021), the customer reported mattress deflation.The arjo representative attended on (b)(6) 2021 and replaced a faulty tubeset (part responsible for transfer of air to the mattress from the pump).Later the same day ((b)(6) 2021) the customer again reported that the mattress was faulty and ordered replacement which was delivered to the ward on (b)(6) 2021.The system involved in the incident was picked up by the arjo representative on 31 aug 2021 because the mattress was again reported as faulty.An inspection conducted on 1 sep 2021 did not reveal any issues.The devices (mattress and pump) operated correctly.According to nimbus 3 instruction for use (151996ml) ¿the nimbus 3 and nimbus 3 professional systems are indicated for the prevention and management of all categories pressure ulcer when combined with an individualized monitoring, repositioning and wound care program.¿ as per design, ¿the low pressure indicator is illuminated whenever the pump detects low pressure within the mattress.¿ pressure injuries are complex and are a result of many factors including: advanced age, immobility, co-morbidities, microclimate, incontinence and lack of being turned or repositioned frequently enough.A support surface is only one of many interventions that are needed in order to prevent pressure injuries.The patient¿s medical condition is unknown.The patient passed away on (b)(6) 2021 and arjo was informed by the nurse that the patient's death was unrelated to the event.The arjo nimbus 3 system was used while the patient developed pressure injuries, therefore it played role in the event.The involved system was malfunctioned therefore it failed to meet its performance specification.The complaint was assessed as reportable due to indication about the serious injury.

• Brand Name: NIMBUS 3 / DFS3
• 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: 12479131
• MDR Text Key: 280817876
• Report Number: 3005619970-2021-00017
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 151010
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention