MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. NIMBUS 4; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 649STD

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 12/12/2023

Event Type  Injury  

Event Description

Arjo became aware of the event involving the nimbus 4 pump and the nimbus professional mattress.The customer alleged that when the patient was lying on his side one of the mattress cells deflated and the patient was feeling the bed frame.Due to that the patient sustained serious pressure injury.The customer also informed that the sinking of the patient was not visible and the pump was not alarming.The problem became apparent when the patient was placed back in the supine position.The system was returned to arjo for evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

Although the customer alleged deflation of the 3rd mattress cell (counting from the mattress head end, located under the patients shoulders), the patient developed thorax serious pressure injury (the customer provided photo confirming the patient outcome, attached to the parent id record).The system inspection did not confirmed the leakage from the mattress cell in the head section.It revealed a small leakage of air from the pump¿s compressor.Moreover, it was found that the mattress heel protector cell was punctured by the cpr plastic frame.The test with weights on the mattress was performed.It revealed that after one hour the mattress surface became fully instable and the weights bottomed out.In the course of the investigation we have learned, thus far, that the patient was lying on his side for 14h.The extended time period when the patient was not repositioned could directly contribute to the patient¿s pressure injury development.Currently we are in the process of gathering and analysing the data in order to conclude the cause of the patient injury.

Manufacturer Narrative

The gathered data are analyzed and compiled.Once the investigation is completed a final report will be submitted.

Manufacturer Narrative

The customer stated that the patient sustained an injury after 14 hours of lying on side.The customer also indicated that they deflated one cell (the 3rd from the top) because of the patient shoulder.The customer stated that they noticed lower pressure in the mattress, when they turned the patient to supine position.Allegedly, the pump was not alarming.The system was tested and it was found that the compressor was leaking and heel protector cell was punctured.Additional analysis requires to verify how those failures influence patient and the sinking of the mattress (if any).

Manufacturer Narrative

Arjo became aware of the event involving the nimbus system (nimbus 4 pump and the nimbus professional mattress).A patient who was lying on his side, in the same position overnight, in active mode, developed a serious pressure injury (deep tissue injury) after 14 hours of therapy on a nimbus professional mattress.The skin damage was located on the right side of the abdomen.The customer claimed that the patient was lying on the ¿slatted frame¿ (it possibly refers to the frame deck) and that there was no alarm.The customer did not see the sinking, they only noticed the issue when they turned the patient back to a supine position.Photographic evidence provided shows a pump with a low-pressure indicator illuminating the yellow light and a mute control active.This indicates that the low-pressure alarm was activated however since the alarm was muted, there might not have been a sound.The system was returned to the arjo rental service center for evaluation.The following faulty components were found: compressor leaking, heel protector cell punctured.Further testing showed that the punctured heel protector caused the mattress to lose air, the compressor leaking did not influence the mattress.The patient was left for 14 hours on one side without repositioning.National pressure ulcer advisory panel, european pressure ulcer advisory panel and pan pacific pressure injury alliance.Prevention and treatment of pressure ulcers/injuries: clinical practice guideline.2019 states that ¿extend period of lying or sitting on a particular part of the body and failure to redistribute the pressure on the body surface can result in sustained deformation of soft tissue and, ultimately, in tissue damage¿.Nimbus 4 instruction for use states that the ¿system are indicated for the prevention and/or management of all categories of pressure ulcer, when combined with an individualised, comprehensive pressure ulcer protocol: for example, repositioning, nutritional support, skin care.¿ ¿the system represents one aspect of a pressure ulcer management protocol; all other aspects of care should be considered by the prescribed clinician¿.The product failed its specification since it was deflating, however, the factors leading to the development of serious pressure injury are complex and can be linked, on its own, with an individual laying in one position for an extended period.Therefore, the link between the development of a serious injury and product failure could not be determined.The arjo nimbus 4 pump and the nimbus professional mattress were used while the patient sustained a serious pressure injury, therefore it played a role in the event.The involved system malfunctioned therefore it failed to meet its performance specification, however, the link between the product failure and the serious pressure injury was not established.The complaint was assessed as reportable due to the indication that the patient developed a serious pressure injury while lying on the arjo system.

• Brand Name: NIMBUS 4
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18474368
• MDR Text Key: 332428971
• Report Number: 3005619970-2024-00001
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 649STD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 130 KG