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	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Arjo became aware of an incorrectly inflated mattress that was described by the customer as ¿inflated like a ball¿.There was no indication of patient involvement, and no injury was sustained.
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
Due to the allegation of an incorrectly inflated mattress described as ¿inflated like a ball,¿ the issue is presumed to be related to overinflation caused by a faulty mattress base (automatt).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." based on the available information, a malfunction of the automatt system appears to be the most probable cause of the reported overinflation.The nimbus professional mattress did not meet its specifications due to the reported incorrect inflation.No patient was involved when the reported issue occurred.No injury was sustained.The complaint was assessed as reportable due to the description that the mattress inflated into a ball, which may suggest mattress base overinflation.

• 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: 23334257
• Report Number: 3005619970-2025-00054
• Device Sequence Number: 10572482
• Product Code: FNM
• UDI-Device Identifier: 05055982782197
• UDI-Public: (01)05055982782197(11)180414
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2018
• 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