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

Model Number 650001DAR

Device Problems Break (1069); Increase in Pressure (1491); Overfill (2404)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjo was informed by arjo distributor that automatt ( a component of nimbus 4 mattress) experienced abnormal inflation from unknown reason.There was no alarm activated on the pump.The distributor reported that the automatt became over inflated with the patient on the mattress and that the mattress was tilting to one side.We report this event to competent authority in abundance of caution taking into account the nature of the failure - automatt overinflated causing that the mattress surface raised and was tilting to one side, as this could lead to patient fall.No injury occurred in relation to this incident.This event occured at the following healthcare facility: (b)(6).

Manufacturer Narrative

This report is being filed under exemption e2012066 by the getinge suzhou ltd (registration #(b)(4) on behalf of the importer arjohuntleigh inc (ahus) (registration (b)(4).Currently, we are waiting for the results from mattress evaluation from our distributor.As soon as all the data is available, the follow-up report will be provided.

Manufacturer Narrative

We have received information from the distributor that the component was replaced, but there was no further details that would allow us to establish the cause of the malfunction.Therefore, a product return is organized to the manufacturer for further evaluation.When additional information and results from the expected evaluation are available, a follow-up report will be provided.

Manufacturer Narrative

Arjo was informed on 12 nov 2018 by arjo distributor that automatt (a component of nimbus 4 mattress) experienced abnormal inflation from unknown reason.There was no traces of leakage, no kinked tubing and no alarm activated on the pump.The distributor reported that the automatt became over inflated with the patient on the mattress and that the mattress was tilting to one side.There was no patient injury.The distributor replaced the automatt (part number 412068) and informed arjo that the issue had been resolved, but no further details were provided that would allow us to establish the root cause of the failure.For this reason, arjo asked the distributor to return the faulty component for manufacturer evaluation.Despite several attempts to contact the distributor, we have not received a response nor the faulty component.Last communication was sent to the distributor on 2 may 2019.Arjo decided to wait no longer for the response and complete the investigation with information available.If new information is available the mdr report will be updated accordingly.Without component evaluation, we have been forced to compare provided information with arjo knowledge about the product.Two potential reasons, of automatt failure, have been taken into account: 1) sensor pad welding was broken.2) the connector inside auto matt became loose from sensor pad.In both occasions there would be a leak, yet according to the distributor no leakage was detected.The 1st option would result in an alarm of high pressure, yet according to distributor there was no alarm.2nd option seems to be the most possible.However, without component evaluation, the mentioned hypothesis cannot be confirmed.Therefore the root cause of automatt failure cannot be determined.In summary, the nimbus 4 mattress was used for a patient treatment when the event occurred and therefore the product played role in the event.Although, no injury occurred in relation to this incident, we report this event to competent authority in abundance of caution taking into account the nature of the failure - automatt overinflated causing that the mattress surface raised significantly and tilted to one side.

Manufacturer Narrative

Because new information was received, we are providing a follow-up report.On 11 oct 2019 new information was provided to the complaint submitted under manufacturer report number.A manufacturer tested the returned nimbus 4 mattress with the following results: during an inflation test, the automatt (a sensor pad incorporated into nimbus mattress, located underneath the mattress cells) inflated to the shape of a balloon, the automatt blue cover was cut to find that tubing inside the blue cover were cracked.Manufacturer indicated that when tube was cracked and the air escaped directly to the blue cover instead of sensor pad.As a result the automatt have overinflated.This symptom is very visible and cannot be omitted and mitigated by caregivers.The results of manufacturer testing confirms the customer's allegation.The exact root cause of the cracked tube remains unknown, however it is suspected that the rolling and folding the mattress during storage might have been an important factor in the tube breakage.If the tube breaks after mattress being rolled or folded, the over inflation will be easy to detect before a patient lays on mattress.When reviewing complaints related to defective automatt we have found none with adverse reaction.Based on the above and lack of evidence that a crack tube inside automatt sensor ever resulted in adverse event, we concluded that the reported failure is not likely to result in an adverse outcome upon recurrence.We will continue to monitor each complaint of this nature, but do not see this failure to be reportable to the competent authority in the future.

• Brand Name: NIMBUS 4
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• MDR Report Key: 8146454
• MDR Text Key: 130181170
• Report Number: 3005619970-2018-00015
• 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,distri
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 650001DAR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2019
• Distributor Facility Aware Date: 11/12/2018
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2019
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 11/12/2018; 11/12/2018; 05/02/2019; 10/11/2019
• Supplement Dates FDA Received: 01/03/2019; 02/01/2019; 05/21/2019; 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR