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

Model Number 152010DAR

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 06/16/2023

Event Type  Injury  

Event Description

On august 17, 2023 arjo received an information from the national agency for the safety of medicines and health products (ansm) informing about the event involving nimbus 3 mattress.It was reported that, on the morning of (b)(6) 2023, the 79-year-old tetraplegic patient was found lying on the deflated mattress.It is not known how long the mattress was deflated.The customer staff reported that the patient¿s sacrum pressure injury deteriorated from stage 2 to stage 4.When the issue was noticed, the mattress was changed immediately.On (b)(6) 2023 the claimed system was subjected to preventive maintenance.It was found that the mattress foot cell was punctured.The arjo technician replaced the faulty part.There was no indication about any alarm issue on the pump.The customer did not inform arjo about an incident in (b)(6), therefore the device was not inspected then.The device was a month later verified as part of preventive maintenance program.

Manufacturer Narrative

Investigation completion is ongoing.A supplemental report will be submitted when investigation is completed.

Manufacturer Narrative

The nimbus 3 instruction for use (151996) states that the involved system is equipped with a sophisticated alarm system that differentiates between normal operation and genuine system faults.The pump worked correctly (no parts were replaced) which means that if a low pressure was detected, an indicator would illuminate on the top and front of the pump and an audible warning would be heard.The alarm system activates after the system detects lower pressure in the mattress.In the event of one cell being punctured, the mattress will not lost pressure immediately.The mattress consists of 20 cells in total.Torso cells are located under the middle section of the mattress and are fed through partial non-return valves from other cells and are therefore never at zero pressure.Their role is to prevent torso section from bottoming during dynamic mode and when a patient is sitting upright.Additionally, the 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.It is unknown whether the therapy regimen has been adapted to the tetraplegic patient¿s condition who would not be able to reposition himself.Based on the above the root cause of this event could not be established.The arjo nimbus 3 system was used while the patient's condition deteriorated, therefore it played a role in the event.The involved system malfunctioned therefore it failed to meet its performance specification, however it is unknown when the foot cell became punctured.Arjo was not notified about an event when it occurred and the mattress was inspected a month later as part of preventive maintenance program.The complaint was assessed as reportable due to the initial indication that the patient developed serious pressure injury allegedly while lying on the arjo system.However, the investigation concluded that the relation between pi development and the use of arjo device was not found.

Event Description

On august 17, 2023 arjo received an information from the national agency for the safety of medicines and health products (ansm) informing about the event involving nimbus 3 mattress.Following the information provided, the 79-year-old tetraplegic patient was found lying on the deflated mattress on the morning of (b)(6) 2023.It is not known how long the mattress was deflated.The customer staff reported that the patient¿s sacrum pressure injury deteriorated from stage 2 to stage 4.When the issue was noticed, the mattress was changed immediately.On 11 july 2023, the claimed system was subjected to preventive maintenance.It was found that the mattress foot cell was punctured, however it is unknown when the foot cell became punctured.Arjo inspected that mattress a month after the event.The arjo technician replaced the faulty part.There was no indication of any alarm issue on the pump.

• 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
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17753991
• MDR Text Key: 323474150
• Report Number: 3005619970-2023-00020
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 152010DAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male