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

Model Number 152010DAR

Device Problems Deflation Problem (1149); Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 07/21/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

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.

Manufacturer Narrative

On 9 september 2019, arjo received an email from the (b)(6) police with information about event involving a homecare resident's in (b)(6).The event occurred on (b)(6) 2018, resident used non arjo solite bed and arjo nimbus 3 system (pump and mattress).The police stated that the caregivers decided to move the resident from an arjo nimbus 3 system because of deflated mattress.During transfer procedures, caregivers broke a patient femur.The resident passed away due to sustained injury.The police found, that the mattress was switched to transport mode and that the control had to be switched manually but the caregivers denied that they activated this function before the event.The transport mode is used to seal the mattress so that the air is not exhausted when the tubeset is disconnected e.G.When it is require to move the resident from one location to another.The transport control needs human interaction to manually turn it to the required position.The control will not turn on its own.Nimbus 3 system was serviced and maintained by (b)(6) stores.The loan store was contacted in order to obtain additional information about the service history of the system.On 13 november 2019, we received service records related to the claimed device.The review of service history did not show any issue related to the transport mode function.Review of post market surveillance data revealed that there was no serious injuries or death related to the activation of the transport mode.If the transport control is set to transport mode and mattress is connected to the working pump, the pump will indicate a low pressure fault alarm.Activation of transport mode is not considered reportable to competent authorities.Based on the above, it is unlikely that activation of transport mode will result in serious injury or death in the future.The injuries patient sustained were not related to the transport mode and deflated mattress but to the transfer procedure, from the arjo mattress, carried out by the caregivers.To conclude, in the process of transferring the patient from the deflated arjo nimbus 3 mattress, caregivers broke patient's femur.Patient passed away due to sustained injuries.Arjo nimbus 3 system played a role in the event, but did not cause or contribute to the patient outcome.The device did not meet its performance specifications because the mattress was found deflated, most likely because it was left on transport mode (there was no technical failure).We report this event to competent authorities an abundance of caution due to initial information that the patient passed away.

• 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: 9080640
• MDR Text Key: 158953217
• Report Number: 3007420694-2019-00151
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

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
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death