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
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.The complaint (b)(4), (manufacturer report no:) 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 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 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
(b)(4).The reported complaint that the "pipeline was leaking" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action is required at this time.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.

• 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: 22026129
• Report Number: 3005619970-2025-00017
• Device Sequence Number: 21110755
• 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
• 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