MAUDE Adverse Event Report: GETINGE (SUZHOU) CO., LTD. NIMBUS 4; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 649STD

Device Problem Air Leak (1008)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon the investigation conclusion.

Event Description

Arjohuntleigh has been informed about an event which occurred with the involvement of nimbus 4 system.It was reported that the mattress deflated with no alarms over the night.As per initial information received, the mattress has deflated completely over the night, "rolling the user backwards and to the side" which resulted in shoulder dislocation and hip pain.It was reported after the user was lifted from the bed, a low pressure alarm was launched.

Manufacturer Narrative

Arjohuntleigh has inspected the involved system and the potential source of air leakage was detected within the compressor assembly - one of its subcomponent revealed fault.Arjohuntleigh is still in the process of data analysis.Additional information will be provided within the report conclusion.

Manufacturer Narrative

An investigation was carried out into this complaint.Arjohuntleigh was informed about an event which occurred with the involvement of nimbus 4 system.It was reported that the mattress deflated with no alarms.As per the initial information received, the mattress has deflated completely over the night, "rolling the user backwards and to the side" which resulted in shoulder dislocation and hip pain.After the user was lifted from the bed, it was reported that a low pressure alarm was launched.When reviewing similar reportable events, we have found a number of cases presenting a similar scenario to the one investigated.There occurrence rate for this failure mode is considered to be low.Involved nimbus system was evaluated by arjohuntleigh representatives.The general condition of mattress and pump was good, with no signs of damages or excessive wear were identified.During the evaluation the system was fully functional and operated correctly.No signs of damages or excessive wear were identified.A functionality test showed that the system was unable to create a sufficient pressure during the first cycle.Inspection of internal components revealed the source of air leakage - a failure of compressor subcomponent.During the testing procedure the low pressure condition was detected by the system and a low pressure alarm was launched.Based on our product knowledge, an air leakage within the system activates the low pressure alarm when reaching a certain level of pressure.Please note that in case of minor leakage in the nimbus system, all air will not automatically be removed from the mattress, but will gradually reduce the amount of air from around the heaviest part of patient's body.The pump will compensate pressure by increased system operation as long as possible.The nimbus low pressure alarm function will activate after 3 consecutive cycles of low pressure (approx.30 minutes from the time air pressure drops below the threshold).The nimbus system is targeted to all categories of pressure ulcers and for patients who are at a high risk.As the nimbus system is commonly used for patients who are at greater risk of developing or have already developed stage 3 or 4 category pu, the majority of units are located in acute environments and each patient is constantly monitored at more regular intervals.Nimbus system is designed for the prevention and management of all categories of pressure ulcers when combined with an individualized monitoring, repositioning and wound care programme.The system represents only one aspect of a pressure ulcer management protocol - all other aspects of care (patient's condition, implemented procedure of monitoring, skin care, regular and frequent re-positioning routine) should be considered by the prescribing clinician.In the event of loss of pressure in the system, the interface pressure between the patient and the device may increase, thus reducing the therapy provided and increasing the risk of the development of a pressure sore (if left unattended).It has been established that nimbus system was being used for a patient therapy at the time of the event.The system was found to have malfunctioned (not performing to specification) when the event took place, which has contributed to the patient's outcome.

• Brand Name: NIMBUS 4
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• Manufacturer (Section G): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 6976665
• MDR Text Key: 90218642
• Report Number: 3005619970-2017-00026
• 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: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: 649STD
• 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: 12/22/2017
• Distributor Facility Aware Date: 09/26/2017
• Event Location: Home
• Date Report to Manufacturer: 12/22/2017
• Date Manufacturer Received: 09/26/2017
• 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): Other