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	04/10/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Arjo was informed about the event related to the nimbus 4 mattress.The customer reported that "3 mattresses were overinflating in an unsafe manner and the bottom of the mattress was hot".There was no indication of patient involvement and no injury was reported.The arjo technician checked the device and stated that the mattress was overinflated due to the faulty automat, and it needed to be replaced.The technician did not confirm the issue related to the heating of the mattress.The complaint (b)(4) (manufacturer report no: 3005619970-2025-00017) refers to the mattress with serial number: (b)(6), the complaint (b)(4) (manufacturer report no: 3005619970-2025-00019) refers to the mattress with serial number: (b)(6), the complaint (b)(4) (manufacturer report no: refers to the mattress with serial number: (b)(6).
Event or Problem Description
Arjo was informed about the event related to the nimbus 4 mattress.The customer reported that "3 mattresses were overinflating in an unsafe manner and the bottom of the mattress was hot".There was no indication of patient involvement and no injury was reported.The arjo technician checked the device and stated that the mattress was overinflated due to the faulty automatt, and it needed to be replaced.The technician did not confirm the issue related to the heating of the mattress; however, the pump may have appeared warm during operation, as it was continuously supplying air to the mattress as part of its normal function.The complaint (b)(4) (manufacturer report no: 3005619970-2025-00017) refers to the mattress with serial number: (b)(6), the complaint (b)(4) (manufacturer report no: 3005619970-2025-00019) refers to the mattress with serial number: (b)(6), the complaint (b)(4) (manufacturer report no: 3005619970-2025-00018) refers to the mattress with serial number: (b)(6).
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 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." in summary, 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 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: 22024582
• Report Number: 3005619970-2025-00018
• Device Sequence Number: 7267264
• Product Code: FNM
• UDI-Device Identifier: 05055982782234
• UDI-Public: (01)05055982782234(11)170815
• 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 Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2017
• Is the Device Labeled for Single Use? (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