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

Model Number	650001DAR
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the nimbus 4 mattress was defective.It was claimed that the left side of the mattress was raised during inflation.The arjo technician inspected the device and found that the automatt was faulty.There was no indication of patient involvement, and no injury was reported.
Additional Manufacturer Narrative
The investigation is ongoing.The conclusions will be provided within the follow-up report once the investigation is completed.The device is distributed outside the us, and no gudid information exists.
Additional Manufacturer Narrative
An inside inspection of the faulty automatt was conducted, and a ruptured hose was found.The investigation is ongoing.The conclusions will be provided within the follow-up report once the investigation is completed.
Additional Manufacturer Narrative
The cause of the automatt over-inflation is an incorrect circulation of the air in the automatt sensor pad (mattress base) due to inner tube damage.The tpu tube may break over time due to the extruding force of the silicone tube and the external bending force (e.G., bending the mattress during transport).The arjo technician inspected the device and confirmed the customer's allegation.The technician found a ruptured hose inside the automatt.The membranes of grommets were punctured.When the grommet membrane is punctured and load is applied on the mattress, air will escape through the punctured membrane, reducing the risk of the automatt over-inflating and the patient's falling.In the complaint at hand, the load was not applied to the mattress (there was no patient involved).This is in line with the instruction for use for nimbus 4 and nimbus professional (649933en): "do not place the patient on the mattress until it is fully inflated and normal operating pressure has been reached." the reported issue was caused by the incorrect circulation of the air in the automatt sensor pad (mattress base) due to the broken tube.In summary, the nimbus 4 mattress did not meet its specifications since the automatt sensor pad was faulty.There was no indication of patient involvement.No injury was claimed.The complaint was decided to be reportable due to the nature of the failure (automatt overinflated).

• Brand Name: NIMBUS 4
• Common Device Name: 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 21759651
• Report Number: 3005619970-2025-00012
• Device Sequence Number: 8463351
• Product Code: FNM
• UDI-Device Identifier: 05055982782234
• UDI-Public: (01)05055982782234(11)180323
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/29/2025; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown