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

Model Number 650001DAR

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.There is not enough information to conduct an investigation.Data collection continues.When conclusion is available the final report will be provided.

Event Description

The mattress component (automatt) overinflated.There was no indication of patient's involvement, no injury.

Manufacturer Narrative

Arjo became aware of the nimbus 4 mattress leakage on the lateral connector and automatt overinflation.Further clarification from the service technician, revealed that the issue was detected at the time of mattress testing after washing in the arjo france service center.No patient was involved and no injury occurred.The cause of the automatt overinflation is the incorrect circulation of the air in the automatt sensor pad (mattress base) due to a damaged inner tube.The tpu (thermoplastic polyurethane) tube may break over time due to the extruding force of the silicone tube and the external bending force, causing air accumulation in automatt.This issue has been address by the field safety corrective action fsn-suz-001-2021.According to the information gathered from the service technician, it is suspected that the automatt sensor pad grommet could have been blocked and therefore the overinflation occurred after washing.The scenario of the automatt overinflation was tested by the manufacturer and the results confirmed that when the weight is applied the overinflation will not occur, the potential risk of the patient fall from the mattress surface is eliminated.The overinflation was discovered during mattress testing and before releasing to the customer, therefore, there was no potential risk of fall.In summary, the nimbus 4 mattress did not meet its specification since the automatt sensor pad was faulty - most likely the gromments were blocked by an obstacle.No patient was involved when the reported issue occurred.No injury was claimed.As per the testing performed by the manufacturer, when the correction is performed in accordance to the instruction provided in the filed action communication, the risk of patient fall will not occur.

• 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: 17057874
• MDR Text Key: 317478565
• Report Number: 3005619970-2023-00013
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 650001DAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/05/2023
• Supplement Dates FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: RES 87752
• Patient Sequence Number: 1
• Patient Outcome(s): Other