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	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the automatt over-inflation is incorrect circulation of the air in the automatt sensor pad (mattress base) due to inner tube damage.The tpu tube (p/n: nmb513) may break over time due to the extruding force of the silicone tube and the external bending force.The membranes of the 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." to sum up, the nimbus 4 mattress did not meet its specifications since the automatt sensor pad was faulty.No patient was involved when the reported issue occurred.No injury was sustained.The complaint was decided to be reportable due to the nature of the failure (automatt overinflated).The device is distributed outside the us and no gudid information exists.
Event or Problem Description
Arjo was informed about the event related to the nimbus 4 mattress.The customer reported that the mattress did not work and was overinflated.There was no indication of patient involvement.No injury was sustained.During the device inspection, the technician confirmed that the automatt was overinflating.The faulty automatt was replaced with a new one and discarded.

• 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: 22837083
• Report Number: 3005619970-2025-00039
• Device Sequence Number: 9423155
• Product Code: FNM
• UDI-Device Identifier: 05055982782234
• UDI-Public: (01)05055982782234(11)190119
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2019
• 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