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	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The nimbus 4 mattress was found in a store for repair by an arjo technician.There was no allegation of failure from the customer.During the device inspection, an arjo technician found that the automatt was faulty, causing the mattress to overinflate.There was no indication of patient involvement, and no injury was reported.The faulty automatt was replaced.The repaired mattress was tested, and it worked as intended.
Additional Manufacturer Narrative
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.The mattress was not corrected as per the field safety corrective action (tw1942837, fsn-suz-001-2021).In summary, the nimbys 4 mattress did not meet its specification since the automatt sensor pad was faulty.No patient was involved when the reported issue occurred.The complaint was assessed as reportable due to the mattress over-inflation (the faulty automatt).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: 23093247
• Report Number: 3005619970-2025-00049
• Device Sequence Number: 13213737
• Product Code: FNM
• UDI-Device Identifier: 05055982782197
• UDI-Public: (01)05055982782197(11)170110
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/19/2025

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: 651001DAR
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2017
• 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