MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - EUR3

Model Number 27031

Device Problems Failure to Calibrate (2440); Battery Problem (2885)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint.The pneumatic block was replaced to address the issue.The device will be serviced and fully tested before returning to the customer.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device failed to complete its internal self test.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 internal battery degraded warning alarm.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported failure to complete its internal self test was due to an isolated component failure within the pneumatic block while the internal battery degraded warning alarm was due to the battery controller software.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 failed to complete its internal self test and displayed an internal battery degraded warning alarm.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 100 - EUR3
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11665959
• MDR Text Key: 245505953
• Report Number: 3007573469-2021-00493
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

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: 27031
• Device Catalogue Number: 27031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2021
• Distributor Facility Aware Date: 05/03/2021
• Device Age: 43 MO
• Date Report to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1