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).

• 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
• Report Date: 03/15/2024

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
• Date Manufacturer Received: 02/16/2024
• 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