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

Model Number 649028

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 arjo was notified about the complaint involving nimbus 3 air pressure mattress.Following the information provided the mattress deflated activating the alarm.The facility staff responded to the alarm.They made a service call and performed their own risk assessment on the basis of which it was determined to leave the resident on the mattress with addition pillows until service technician arrives.There was no injury sustained as a result.

Manufacturer Narrative

Investigation has been carried out to this complaint and conclusions are following.Customer reported that a quadriplegic patient was left on a deflated mattress over the weekend.Arjo service technician attended the customer for assistance.The technician found that shuttle valve was faulty therefore it was replaced.Following the information provided by arjo technician, the system activated an alarm, which alerted the client.There was no injury associated with this event.A caregiver used a pillow to support the patient.Product instruction for use 151996au_05 states: "it is responsible of the care giver to ensure that the user can use this product safely"."the nimbus 3 systems are indicated for the prevention and management of all categories of pressure ulcer when combined with an individualized monitoring, repositioning and wound care programme"."the low pressure indicator is illuminated whenever the pump detects low pressure within the mattress".In troubleshooting section of this manual, in case low pressure alarm is activated, the possible causes are listed along with remedies.One of the possible remedy is to call the service engineer.The facility staff called the arjo technician, who attended the facility and repaired the pump by replacing faulty component.The guidelines include in the ifu are only recommendations and should not replace clinical judgement.In the complaint at hand the caregivers responded to the alarm performing their own risk assessment on the basis of which they determined to leave the patient on the mattress over the weekend with addition pillows until service technician arrived.Shuttle valve failure is not considered safety related.There is safety feature built in the system - alarm.Apart from that the repositioning regimen plays significant role in patient care.In summary, the mattress failed to meet its performance specification as it deflated because of faulty shuttle valve, but the pump sensed the low pressure and activated an alarm as per the product design.Although the alarm alerted caregivers, the patient was left on deflated mattress over the weekend supporting with pillows, and in that way the mattress played role in the event.Decision to report this case was based on assumption that leaving the patient on a deflated surface might contribute to the injury.We assumed that the reported event could be a device-related error made by the person using the device, however there was no injury sustained in relation to the event.

Manufacturer Narrative

This report is submitted to add information to section d4, to correct data in section d1, d3, g1-2 (continued) and add proper quotation from nimbus 4 product instruction for use instead of quotation from nimbus 3 product instruction for use.The investigation conclusion remains unchanged.Product instruction for use 649933en_03 states: "the nimbus 4.Systems are indicated for the prevention and/or management of all categories of pressure ulcer, when combined with an individualised, comprehensive pressure ulcer protocol: for example, repositioning , nutritional support, skin care".

• Brand Name: NIMBUS 4
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; jiangsu; suzhou, 21502 4; CH 215024
• MDR Report Key: 8230613
• MDR Text Key: 133935621
• Report Number: 3005619970-2019-00002
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2019,09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 649028
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2019
• Distributor Facility Aware Date: 12/17/2018
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 02/08/2019
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other