MAUDE Adverse Event Report: RESMED LTD AIRCURVE 10 CS-A TJ; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Cardiac Arrest (1762)

Event Date 04/21/2023

Event Type  malfunction  

Event Description

It was reported to resmed that a patient experienced deterioration of respiratory condition and subsequent cardiopulmonary arrest after starting use of an aircurve 10 cs-a device to address worsening respiratory condition.Device had displayed an error 021.Initial inspection of the device revealed the device was flooded with water.Patient was provided life-saving treatment and switched to an in-hospital ventilator.Patient's condition stabilized.

Manufacturer Narrative

The device was returned to a third party service center.Visual inspection confirmed the device was flooded with water.Review of the device logs confirmed error 021 and revealed the device displayed 'pressure sensor dual check failed' alarm.Trigger of the alarm causes therapy to stop until the alarm is deactivated.The aircurve 10 cs-a user guide provides the following indications for use: ¿the aircurve 10 cs-a is intended to use for assisting respiration of spontaneously breathing patients with a weight greater than 30 kg at medical facilities and home use.¿ it is only intended to provide ventilation to a spontaneously breathing patients as it is not a life support ventilator.In the event of device failure, an indicated patient would be able to continue breathing spontaneously until an alternative means of ventilation support can be provided.The user guide also provides the following warning: the device is not suitable for ventilator dependent patients.¿ the investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.Resmed reference #: (b)(4).

Manufacturer Narrative

The reported event occurred outside the us.During a routine check of complaints records it was detected that the device aircurve 10 cs-a involved in the event is not marketed in the united states.The aircurve 10 cs-a device (or similar device) has not been cleared or approved for use in the u.S.Therefore, this event does not meet the reportability requirements as described in section 21 cfr 803.50.This report is being submitted to correct the error.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that a patient experienced deterioration of respiratory condition and subsequent cardiopulmonary arrest after starting use of an aircurve 10 cs-a device to address worsening respiratory condition.Device had displayed an error 021.Initial inspection of the device revealed the device was flooded with water.Patient was provided life-saving treatment and switched to an in-hospital ventilator.Patient's condition stabilized.

• Brand Name: AIRCURVE 10 CS-A TJ
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 17000085
• MDR Text Key: 315908713
• Report Number: 3004604967-2023-00369
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498282807
• UDI-Public: (01)00619498282807(10)1482198
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/19/2023
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 07/19/2023
• Supplement Dates FDA Received: 07/20/2023
• Date Device Manufactured: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female