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

Model Number TO BE DETERMINED

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

Arjo became aware of the event resulting in patient¿s stage 4 pressure injury development.The customer reported that the nimbus 4 mattress deflated at the sitting area and the pump¿s alarm did not activate.The patient was not supported properly enough and was almost lying on the bed frame.The mattress deflation was also observed when the transport mode was turned on.Moreover, the customer reported signs of wear on the mattress.The mattress was taken out of use and is awaiting for the inspection.

• 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: 19048673
• MDR Text Key: 339431750
• Report Number: 1419652-2024-00031
• 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
• Type of Report: Initial
• Report Date: 04/05/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TO BE DETERMINED
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2024
• Distributor Facility Aware Date: 03/07/2024
• Date Report to Manufacturer: 04/05/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 100 KG