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 Local Reaction (2035); Discomfort (2330)

Event Date 02/05/2017

Event Type  malfunction  

Manufacturer Narrative

This report is report is being filed under exemption (b)(4) by arjohuntleigh (b)(4) on behalf of the importer (b)(4).Additional information will be provided upon the investigation conclusion.

Event Description

Arjohuntleigh received an information about an event which occurred with the involvement nimbus 3 system.It was reported that the mattress deflated when in use with the patient.A (b)(6) obese patient, bedridden because of digestive surgery with "hartmann intervention" by laparotomy, needed an air mattress due to an altered skin condition (located at sacrum and back) since the (b)(6) 2017.The mattress was received the (b)(6) at the evening and installed on saturday, the 4th.It was indicated that a leakage in the system occurred was noticed on sunday, the 5th in the afternoon (the source is yet unknown).The mattress was replaced after 3h.As a remedial action, the caregiver located the patient on a chair while waiting for service.This created a discomfort and an aggravation of altered skin condition (fibrin deposition located at the back).Even though a low pressure alarm on the pump was working, the time spent by patient lying on a flat surface remained unknown.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.On (b)(6) 2017 arjohuntleigh received an information regarding an event which occurred with the involvement of nimbus 3 system.A patient who was bedridden because of digestive surgery needed an air mattress due to an altered skin condition (located at sacrum and back).On the next day after the installation a leakage in the system was noticed - pump unit was alarming low pressure.The source of mattress leakage was located in mattress cell.Even though a low pressure alarm on the pump was working, the time spent by patient lying on a flat surface remained unknown.As a remedial action, a caregiver placed the patient on a chair while waiting for service.This created a discomfort and an aggravation of altered skin condition (fibrin deposition located at the back).Final assessment of received injury did not consider any serious patient's outcome.When reviewing similar reportable events, we have found no other cases presenting a similar scenario as the one investigated.The event is considered to be an isolated issue.Following the information gathered, it was possible to indicate the reason for mattress deflation - a leakage of the cell occurred.Although the mattress has failed, a designed mitigation factor was fully functional and alerted caregivers about the system malfunction.The staff acted properly by removing the patient from a malfunctioning mattress, however, a period of time spent by the patient on a hard surface is unknown.A remedial action including patient's re-location to the chair with no pressure relief features appears to have led to the deterioration of skin condition, already weakened and prone to injuries.Nimbus 3 system is incorporated with several designed mitigation factors including dedicated pump alarms which are supposed to alert the user in case of system malfunction which may possibly trigger a hazardous situation for the patient.This element of product functionality was still in place at the time of the event.Nevertheless, the therapy with nimbus system represent only one aspect of pressure ulcer management protocol.The procedure should be regularly reviewed by caregiving staff, especially in case of an unexpected failure of one of the protocol's elements (device malfunction).Then, the regimen of care should be re-assessed, focusing on other available aspects of care.Basing on the above, despite a fully functional designed mitigation factor (a low pressure alarm) which was alerting the caregiver, it is suspected that no immediate action was taken and the implemented remedial action towards the patient did not prevent from worsening of patient's condition.Possible sequence of events presented above seems to be the most probable and in line with the event description.The root cause of the reported event is considered to be use error- an incorrectly applied pressure ulcer management and individual patient's assessment.Arjohuntleigh suggests to remind the staff involved of the device labeling, with a special attention paid towards the need of frequent patient's assessment.This is to be communicated to the customer.It has been established that the nimbus 3 system was being used for a patient therapy at the time of the event and has malfunctioned (did not perform up to specification).The system have contributed to a delay in therapy for the patient, however, an incorrectly adjusted patient's care procedure has contributed to the outcome of the event.

• 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; komorniki, PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, PL-62-052 ; PL PL-62052
• MDR Report Key: 6391158
• MDR Text Key: 69757166
• Report Number: 3007420694-2017-00055
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: 152010DAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2017
• Distributor Facility Aware Date: 02/09/2017
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2017
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2010
• 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
• Patient Age: 69 YR