MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 152010DAR

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

On august 17, 2023 arjo received an information from the national agency for the safety of medicines and health products (ansm) informing about the event involving nimbus 3 mattress.It was reported that, on the morning of (b)(6) 2023, the 79-year-old tetraplegic patient was found lying on the deflated mattress.It is not known how long the mattress was deflated.The customer staff reported that the patient¿s sacrum pressure injury deteriorated from stage 2 to stage 4.When the issue was noticed, the mattress was changed immediately.On 11 july 2023 the claimed system was subjected to preventive maintenance.It was found that the mattress foot cell was punctured.The arjo technician replaced the faulty part.There was no indication about any alarm issue on the pump.The customer did not inform arjo about an incident in june, therefore the device was not inspected then.The device was a month later verified as part of preventive maintenance program.

• Brand Name: NIMBUS 3 / DFS3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• MDR Report Key: 17754494
• MDR Text Key: 323473997
• Report Number: 1419652-2023-00051
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 152010DAR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2023
• Distributor Facility Aware Date: 08/17/2023
• Date Report to Manufacturer: 09/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male