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

Model Number 152010DAR

Device Problem Air Leak (1008)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjohuntleigh, a branch of (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted.Additional information will be provided upon the conclusion of investigation.

Event Description

Arjohuntleigh was informed about the incident which occurred with the involvement of nimbus 3 system.It was indicated that the patient using the device was diagnosed with terminal secondary cancer.In past 4 weeks the illness's progression was observed, increasing immobility consequently resulted in pressure sores towards the end of her life.The nimbus system was primarily ordered for the pressure sores and general comfort due to the incredible pain the patient was suffering as a result of the cancer.Within half an hour of patient being on the mattress it became apparent that it was faulty.It was indicated that the mattress deflated around patient during the night.The patient passed away on (b)(6).Patient death was expected, arjohuntleigh device caused patient's physical discomfort however did not contribute to the patient's death.

Manufacturer Narrative

This report is report is being filed under exemption e2012070 by (b)(4).Manufacturer's narrative: an investigation was carried out into this complaint.On (b)(6) 2017 arjohuntleigh received information regarding an event which occurred on (b)(6) 2015.A nimbus 3 system was ordered for an immobile patient, in a homecare setting, for the relief of pressure sores, and general comfort because of significant pain from terminal secondary cancer.The mattress was delivered on 9th aug 2017 in the afternoon.It was reported that within a half hour of placement on the mattress, it had deflated around the patient's body.The patient had to be moved to a replacement mattress which resulted in increased pain experienced by the patient.Unfortunately, the patient passed away on (b)(6) 2017.Following further information gathered by the customer facility representative, patient's death was expected due to her frail health state and terminal illness.A review of similar reportable events, has found no other cases presenting a similar scenario to the one investigated here.The occurrence rate for this failure mode is very low.The customer issued an allegation that the mattress was received faulty: "on the initial unpacking of this mattress it showed a fault, however the delivery person assured (.) that this fault had been rectified." this statement was verified with a service engineer statement - an initial fault of the mattress was identified within the first 10 minutes of mattress inflation.The pump started to alarm low pressure which was due to a loose tube set connection.The technician detached and reattached the tube set, turned the pump off and back on (in accordance with service procedure described in service manual ser0001) which addressed and eliminated the fault - pump was no longer alarming.The mattress was then observed for the next half an hour, until it fully inflated.The device was found to be working properly, as per manufacturer's specification and was released for further use.The mattress was swapped underneath the resident's body and strapped to the bed frame by the arjohuntleigh representative.The mattress was left working properly, without any alarm.Half an hour after patient's placement on the mattress, it started to deflate.Device inspection conducted during arjohuntleigh representative visit, the source of leakage was identified in one of mattress components.The fragility of the patient's health made service not possible, with the patient on the mattress, a replacement system was offered.The patient was transferred to another arjohuntleigh replacement mattress was arranged and successfully completed with the support of arjohuntleigh representative.In the course of investigation it was confirmed that although patient pains intensified, the patent did not suffer any further serious outcomes in relation to mattress malfunction or the transfer.The patient's death which occurred a few days after the reported event was not a result of arjohuntleigh device malfunction.Following the statement of arjohuntleigh representatives who attended the service call, provided training records, and device evaluation results, the system was fully functional when left with the customer.Although the mattress component malfunction occurred during the therapy, a low pressure alarm, a design risk mitigation factor, was operating properly, alerting the user of a low pressure condition within the system.Due to the nature of this incident we are reporting the event in abundance of caution, with deference to the patient's condition (prone to injuries due to a poor health state) and the unfortunate event of patient's death.It has been established that nimbus system was being used for a patient therapy at the time of the event.The mattress was found to have malfunctioned (not performing to specification) when the event took place, however, the malfunction did not result in a serious injury which could have contributed to the patient's outcome.Arjohuntleigh found no direct correlation between patient's death and the reported problem.

• Brand Name: NIMBUS 3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; houghton hall business park; komorniki, PL-62 052; PL PL-62052
• 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. piotra wawrzyniaka 2; komorniki, PL-62-052 ; PL PL-62052
• MDR Report Key: 6799813
• MDR Text Key: 83204449
• Report Number: 3007420694-2017-00176
• 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: company representative,consum
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 152010DAR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2017
• Distributor Facility Aware Date: 08/10/2017
• Device Age: 7 YR
• Event Location: Home
• Date Report to Manufacturer: 10/05/2017
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2009
• 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): Other