MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O NIMBUS 3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 152010DAR

Device Problem Decrease in Pressure (1490)

Patient Problem Death (1802)

Event Date 07/21/2018

Event Type  Death  

Event Description

Arjo received information about a patient death.An elderly female care home resident in (b)(6) was using a nimbus 3 mattress and pump.At night care staff have gone to the residents room and have found the mattress deflated.Carers moved the resident from the mattress and on doing so break her femur.The resident died from the injury.It was mentioned that the mattress switch was set to transport mode, but carers deny touching the dial to transport mode.The dial was stiff and had to be physically moved from normal to transport mode.

• Brand Name: NIMBUS 3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 9080645
• MDR Text Key: 158939678
• Report Number: 1419652-2019-00195
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 152010DAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2019
• Distributor Facility Aware Date: 09/09/2019
• Device Age: 7 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death