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

Model Number 151010

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 06/15/2022

Event Type  Injury  

Event Description

On 15 jun 2022, arjo was notified, at time of pick-up of the nimbus 3 system that a condition of patient¿s who was using the system had deteriorated due to alleged system breakdown (not pumping up, not alarming).The patient had documented history of deteriorating pressure injuries.At time of pick up the system, he had pressure injury category unstagable to sacrum and left buttock and category 2 to right buttock.He required a treatment with a careful hygiene regime, dressings and repositioning.

• 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: 14985617
• MDR Text Key: 295685724
• Report Number: 1419652-2022-00033
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2022

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: Other
• Device Model Number: 151010
• 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: 07/12/2022
• Distributor Facility Aware Date: 06/15/2022
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male