MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. NIMBUS 4; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 649015

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 10/30/2022

Event Type  Injury  

Event Description

On 13 jan 2023, arjo became aware of the second event that involved the same bedridden patient with very little mobility as in the medwatch ref.1419652-2022-00048.This report refers to the event that occurred on (b)(6) 2022, the patient sustained a sacral ulcer with exposed underlying tissue.The patient used at that time the nimbus system that consisted of the nimbus pump serial number (b)(4) and the nimbus professional mattress serial number (b)(4).The patient¿s wound required daily monitoring using the bandages, the hydrofiber was applied after mechanical debridement.The system involved in the event was allegedly faulty, the customer staff informed about the pump failure and the mattress deflation.

• Brand Name: NIMBUS 4
• Type of Device: 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: 16251969
• MDR Text Key: 308233859
• Report Number: 1419652-2023-00006
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 649015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2023
• Distributor Facility Aware Date: 01/13/2023
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 71 KG