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

Model Number 152010DAR

Device Problem Decrease in Pressure (1490)

Patient Problem Pressure Sores (2326)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation has been carried out to this complaint and conclusions are following.Arjo was informed about an event involving nimbus 3 system.A patient was placed on nimbus 3 mattress on (b)(6) 2018.The patient was intubated and hemodynamically unstable and could not be turned from (b)(6) till (b)(6), as stated by the customer facility representative.On inspection of patient's skin on (b)(6), pressure injuries to both buttocks were noticed.It was reported that mattress was deflated and patient was laying on a bed frame.Patient sustained unstageable pressure injuries to both buttocks.The system is part of arjo rental fleet.The system was evaluated by arjo service personnel on (b)(4) 2018.It was found that mattress had "lose" connection to cpr module and cells had needle holes.After reconnecting sensor pad hoses to cpr module, a pressure test was performed.Needle holes did not influence mattress performance and did not cause the deflation.The system was tested for 5 days with 200kg weight applied on the mattress surface, at the service center.The system was found fully functional.The cause of mattress deflation was sensor pad hoses disconnected from the cpr module.However, the system is equipped with transport mode system utilized, for instance, in case a patient needs to be transferred to another room.When the nimbus 3 system is set to transport mode, it seals the mattress creating an equally pressurized support surface.As per design, even if sensor pad hoses disconnected from cpr it will not result in immediate mattress deflation.Transport mode will support the patient up to 12 hours.In a reported event it was confirmed that the system activated a low pressure alarm warning caregivers, yet due to patient's serious medical condition (hemodynamically unstable) it was not possible to move the patient or turn on the mattress.As a result patient sustained unstageable pressure injuries to both buttocks.A patient had applied granuflex on affected area and pillows under buttock to prevent direct pressure.The reported situation is singular occurrence connected to exceptional situation when patient's medical condition did not allow to provide proper skin care protocol and repositioning, which in consequences resulted in serious pressure ulcer.In summary, the system was used for patient treatment when the reported event occurred, the system failed to meet its performance specification since sensor pad hoses became disconnected.We report this incident due to serious injuries sustained as a result of unique circumstances - patient's medical condition and not due to product failure.A failure found within the mattress - sensor pad hoses disconnected from the cpr module - on its own will not cause or contribute to serious injury since there are mitigation factors in place such as: alarm, mattress can be set into transport mode.

Event Description

Arjo was informed about an event involving nimbus 3 system.A patient was placed on nimbus 3 mattress on (b)(6) 2018.The patient was intubated and hemodynamically unstable and could not be turned from (b)(6) till (b)(6).On inspection of patient's skin on (b)(6), pressure injuries to both buttocks were noticed.It was reported that mattress was deflated and patient was laying on a bed frame.Patient sustained unstageable pressure injuries to both buttocks.

• Brand Name: NIMBUS 3 MATTRESS
• 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
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 7998948
• MDR Text Key: 124817429
• Report Number: 3007420694-2018-00206
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/24/2018

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?: No
• Device Operator: Other
• Device Model Number: 152010DAR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2018
• Distributor Facility Aware Date: 09/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2018
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 34 YR
• Patient Weight: 186