MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. NIMBUS PROFESSIONAL; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	651001DAR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Arjo was informed by the patient receiving treatment at home about the event related to the nimbus professional mattress.The patient's condition deteriorated at the time of use of the nimbus professional, and the pressure injuries developed.According to the arjo representative, the mattress was working well (as intended) and the customer was trained on how to use the nimbus professional along with the dri-flow and skin iq 365.Arjo was informed that the patient is paraplegic receiving treatment at home.The patient has had pressure sores in the past and is prone to pressure sores.After about a week of use of the nimbus professional mattress, the patient developed new pressure injuries.Before the nimbus professional, the patient used another mattress (therakair visio) for about 20 years.The patient decided to return to the therakair visio mattress when the new sores developed.The patient stated that one of the pressure injuries heal after returning to the previous mattress and other one (after 2 months) still required a mesh.The evaluation of the claimed device conducted by the arjo technician showed that the nimbus professional was working properly and no faults were found.The technician also stated that the function tests were performed before installing the mattress at the patient's house and the parameters were well set.The instruction for use for nimbus 4 and nimbus professional (649933) states that one of the key factor in patient care is a patient's skin care management protocol and that if the patient's condition changes a therapy should be reviewed."the nimbus (.) systems are indicated for prevention and/or management of all categories of pressure ulcer, when combined with an individualised, comprehensive pressure ulcer protocol: for example, repositioning, nutritional support, skin care.Selection should be based upon a holistic assessment of the patient¿s individual care needs.These systems represent one aspect of a pressure ulcer management protocol (¿) if existing wounds do not improve or the patient¿s condition changes the overall therapy regimen should be reviewed by the prescribing clinician.¿ the arjo nimbus professional mattress was used while the patient developed pressure injuries, therefore it played a role in the event.Based on the results of the device evaluation, there was no product malfunction.Pressure injuries are complex and are a result of many factors including: advanced age, immobility, co-morbidities, microclimate, incontinence, and lack of being turned or repositioned frequently enough.Considering all the above information, the root cause of pressure sore development could be related to the patient's health condition and an unsuitable surface for the patient.The complaint was assessed as reportable due to the indication of the serious injury.

• 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
• MDR Report Key: 21178065
• Report Number: 1419652-2024-00072
• Device Sequence Number: 18323439
• Product Code: FNM
• UDI-Device Identifier: 05055982782197
• UDI-Public: (01)05055982782197(11)210121
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2024
• Report Date (Section F): 12/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 651001DAR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/30/2024
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 12/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Patient Weight: 104 KG
• Date Report Sent to FDA: 12/18/2024