MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 DBL KIT FRA; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27074

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/24/2023

Event Type  Injury  

Manufacturer Narrative

The astral device was returned to resmed.The investigation methods, results, and conclusions are not finalized at this stage.If further information becomes available, a supplementary report will be submitted.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that a hospitalized patient experienced severe desaturation of blood oxygen allegedly due to an astral 150 device unexpectedly stopped ventilation.The patient was removed from the device and placed an alternate device.The patient has recovered.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed¿s risk associated with use of the device remains acceptable.The astral 100/150 user guide provides the following warnings:- ¿for ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device.Failure to do so may result in patient injury or death.Ventilator-dependent patients should be continuously monitored by qualified personnel or adequately trained carers.These personnel and carers must be capable of taking the necessary corrective action in the event of a ventilator alarm or malfunction.¿ resmed reference#: (b)(4).

Event Description

It was reported to resmed that a hospitalized patient experienced severe desaturation of blood oxygen allegedly due to an astral 150 device unexpectedly stopped ventilation.The patient was removed from the device and placed an alternate device.The patient has recovered.

• Brand Name: ASTRAL 150 DBL KIT FRA
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• 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: 17393337
• MDR Text Key: 319737247
• Report Number: 3004604967-2023-00448
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270743
• UDI-Public: (01)00619498270743(10)1581451
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172875
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27074
• Device Catalogue Number: 27074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/31/2023
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male