MAUDE Adverse Event Report: RESMED LIMITED AIRCURVE S/T-A; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number AIRCURVE S/T-A

Device Problem Failure to Transmit Record (1521)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2020

Event Type  malfunction  

Event Description

The non-invasive ventilation program in the sleep center writes orders for cpap and bipap and our dme partners typically decide which machines to provide to the patient.The machines have an internal recording device that records both usage and other clinical data.Some years ago we had noticed that the machines were not always recording all the time the patient used the machine.Then we had two young patients within about a month of each other that the parents reported that the child was using the mask significantly more than the machine recorded.This caused us to investigate further.The manufacturer, resmed, stated that it was because the machine was not approved for patients under 66 lbs (it is common practice to use adult machines for children, as traditionally there have been no pediatric units).Resmed subsequently recommended that we use the machine resmed aircurve s/t-a for these smaller patients, as it is fda approved for 30 lbs and more.We changed our practice and started to order this machine.However, we started to notice the same problem even with these patients, for instance the patient about which this report was written.His parents reported that he was using his machine many more hours than it was recording.Upon a closer investigation of his report, it was noted that often his tidal volume would drop below 100 ml, at which point the machine would stop recording.Resmed has informed us that their recording algorithm is set up to stop recording if the tidal volume drops below 100ml.This is to prevent recording time that patients are not actually using their machine (i.E.They took their mask off and it is laying on the pillow), however, it is too sensitive for pediatric patients.This machine specifically is fda approved for patients 30lbs or up.If you calculate a tidal volume for a patient that is 30lbs it calculates to right around 100 ml.However, resmed also informed us that this unit, the s/t-a has the same recording algorithm as it's adult counterparts.The greatest risk from the data not recording comes from the fact that insurance companies use the data to determine continued payment and the machine can be removed from the home if the data does not show usage at least 4 hours per night 70% of the time.The lack of recorded data also has an impact clinically since the data is not available for review by the physician.Manufacturer response for bilevel machine, resmed aircurve s/t-a (per site reporter).This machine specifically is fda approved for patients 30lbs or up.The s/t-a has the same recording algorithm as it's adult counterparts.

Event Description

The non-invasive ventilation program in the sleep center writes orders for cpap and bipap and our dme partners typically decide which machines to provide to the patient.The machines have an internal recording device that records both usage and other clinical data.Some years ago we had noticed that the machines were not always recording all the time the patient used the machine.Then we had two young patients within about a month of each other that the parents reported that the child was using the mask significantly more than the machine recorded.This caused us to investigate further.The manufacturer, resmed, stated that it was because the machine was not approved for patients under 66 lbs (it is common practice to use adult machines for children, as traditionally there have been no pediatric units).Resmed subsequently recommended that we use the machine resmed aircurve s/t-a for these smaller patients, as it is fda approved for 30 lbs and more.We changed our practice and started to order this machine.However, we started to notice the same problem even with these patients, for instance the patient about which this report was written.His parents reported that he was using his machine many more hours than it was recording.Upon a closer investigation of his report, it was noted that often his tidal volume would drop below 100 ml, at which point the machine would stop recording.Resmed has informed us that their recording algorithm is set up to stop recording if the tidal volume drops below 100ml.This is to prevent recording time that patients are not actually using their machine (i.E.They took their mask off and it is laying on the pillow), however, it is too sensitive for pediatric patients.This machine specifically is fda approved for patients 30lbs or up.If you calculate a tidal volume for a patient that is 30lbs it calculates to right around 100 ml.However, resmed also informed us that this unit, the s/t-a has the same recording algorithm as it's adult counterparts.The greatest risk from the data not recording comes from the fact that insurance companies use the data to determine continued payment and the machine can be removed from the home if the data does not show usage at least 4 hours per night 70% of the time.The lack of recorded data also has an impact clinically since the data is not available for review by the physician.Manufacturer response for bilevel machine, resmed aircurve s/t-a (per site reporter) this machine specifically is fda approved for patients 30lbs or up.The s/t-a has the same recording algorithm as it's adult counterparts.

• Brand Name: AIRCURVE S/T-A
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESMED LIMITED; 9001 spectrum center blvd; san dieago CA 92123
• MDR Report Key: 10527469
• MDR Text Key: 206730239
• Report Number: 10527469
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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: AIRCURVE S/T-A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2020
• Event Location: Home
• Date Report to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1460 DA
• Patient Weight: 18