MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - AMER; Continuous, ventilator, home use

Model Number 27001

Device Problem Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed for an extensive engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.If more information becomes available, a supplemental report will be submitted.Resmed reference#: (b)(4).Device received, evaluation pending.

Event Description

It was reported to resmed that an astral device displayed an error message (sf101) related to pressure measurement.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs confirmed the reported complaint, however, performance testing could not reproduce the reported complaint.The device was serviced and fully tested before it was returned to the customer.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to contamination.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device displayed an error message (sf101) related to pressure measurement.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 100 - AMER
• Type of Device: Continuous, ventilator, home use
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 15856914
• MDR Text Key: 304280359
• Report Number: 3007573469-2022-00779
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270019
• UDI-Public: (01)00619498270019(11)210923(10)1559873
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/08/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27001
• Device Catalogue Number: 27001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2023
• Distributor Facility Aware Date: 01/10/2023
• Device Age: 13 MO
• Event Location: Home
• Date Report to Manufacturer: 02/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1