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	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.Udi: (b)(4).The device is distributed outside the us and no gudid information exists.
Event or Problem Description
During the mattress installation at the customer facility, the mattress overinflation occurred.There was no patient involvement and no injury was sustained.
Additional Manufacturer Narrative
The mattress overinflation occurred during the mattress installation at the customer facility by the arjo technician who reported the issue.There was no patient involvement and no injury was sustained.The mattress had faulty automatt and the automatt was replaced with a new one.Following the manufacturer's investigation, the automatt tpu tube may break over time due to the extruding force of the silicone tube and the external bending force.When the tube breaks the air may "accumulate" in the matt, however if the automatt grommet membranes are punctured, air will escape through the membranes when a load is applied on the mattress, and therefore reducing the risk of the automatt over-inflating and patient falling.The faulty automatt was not available for evaluation, therefore the reason for the reported overinflation is unknown.In summary, 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 claimed.The complaint was decided to be reportable due to the nature of the failure (automatt overinflated).H3 other text : mattress discarded.

• 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: 21041380
• Report Number: 3005619970-2024-00055
• Device Sequence Number: 12655693
• Product Code: FNM
• UDI-Device Identifier: 05055982782197
• UDI-Public: (01)05055982782197(11)180414
• Combination Product (Y/N): N
• 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): 01/24/2025

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: 12/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/24/2025
• 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