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

Model Number	651001DAR
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Arjo was informed about the event involving nimbus professional mattress.The customer reported that the mattress was faulty and overinflated.There was no indication of patient involvement, and no injury was sustained.During the mattress inspection, an arjo technician confirmed a customer's allegation.The mattress was overinflated due to the faulty automatt.
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 membrane of the grommet was 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 professional 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.

• Brand Name: NIMBUS PROFESSIONAL
• 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: 22911022
• Report Number: 3005619970-2025-00045
• Device Sequence Number: 9110943
• Product Code: FNM
• UDI-Device Identifier: 05055982782197
• UDI-Public: (01)05055982782197(11)180507
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: 651001DAR
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES# 87752
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown