MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL 100 - APAC2; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27082

Device Problems No Audible Alarm (1019); Unexpected Therapeutic Results (1631)

Patient Problem Cardiac Arrest (1762)

Event Date 07/19/2023

Event Type  Injury  

Event Description

It was reported to resmed that in (b)(6) 2023, a patient experienced cardiac arrest while using an astral 100 device in which allegedly the "air pump stopped working" and alarms were inaudible.Patient's daughter reported that after she replaced the circuit of the device, the device resumed normal operation.The patient was hospitalized and subsequently expired in (b)(6) 2023 while using an unknown device.Patient's cause of death has not been disclosed to resmed.

Manufacturer Narrative

Resmed has requested for the astral device and the device usage records to be returned so that an engineering investigation can be performed, however, the device or the device usage records have not been returned to resmed.Review of the device usage records by a third-party servicer revealed no abnormal findings, including on the date of cardiac arrest.If further information becomes available, a supplemental report will be submitted.Resmed reference#: (b)(4).

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs confirmed no abnormal findings.The investigation determined there was no fault found with the returned device.The device was performing to specifications.Per clinical assessment, there is currently no indication to suggest a device malfunction had occurred and caused or contributed to the patient¿s reported cardiac incident and subsequent death 2 months after.Astral 100/150 user guide provide the following warning: - ¿report unusual chest pain, severe headache or increased breathlessness to your physician.¿ astral 100/150 user guide also warns: - ¿if you notice any unexplained changes in the performance of the device, if it is making unusual or harsh sounds, if the device or the power supply are dropped or mishandled discontinue use and contact your healthcare provider.¿ resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that in (b)(6) 2023, a patient experienced cardiac arrest while using an astral 100 device in which allegedly the "air pump stopped working" and alarms were inaudible.Patient's daughter reported that after she replaced the circuit of the device, the device resumed normal operation.The patient was hospitalized and subsequently expired in october 2023 while using an unknown device.Patient's cause of death has not been disclosed to resmed.

• Brand Name: ASTRAL 100 - APAC2
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 18293577
• MDR Text Key: 330066580
• Report Number: 3007573469-2023-00676
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 27082
• Device Catalogue Number: 27082
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2024
• Distributor Facility Aware Date: 03/27/2024
• Device Age: 14 MO
• Event Location: Home
• Date Report to Manufacturer: 04/09/2024
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female