MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - EUR4

Model Number 27061

Device Problem No Display/Image (1183)

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

Event Date 01/14/2022

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.When more information is available a supplemental report will be submitted.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an astral device displayed an error message (sf192) related to power to sensor board.There was no patient harm or serious injury reported as a result of this incident.

Event Description

It was reported to resmed that an astral device displayed an error message (sf192) related to power to sensor board.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 and performance testing confirmed the reported complaint.Visual inspection of the sensor circuit board revealed a defective solder joint.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to soldering process during manufacturing.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

• Brand Name: ASTRAL 100 - EUR4
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 13601817
• MDR Text Key: 288312064
• Report Number: 3007573469-2022-00118
• Device Sequence Number: 1
• Product Code: FQL
• UDI-Device Identifier: 00619498270613
• UDI-Public: (01)00619498270613(11)210901(10)1557630
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/23/2022

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: 27061
• Device Catalogue Number: 27061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2022
• Distributor Facility Aware Date: 04/28/2022
• Device Age: 4 MO
• Date Report to Manufacturer: 05/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1