MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - FUKUDA

Model Number 27093

Device Problems Failure of Device to Self-Test (2937); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an authorized resmed third party service center for an evaluation and service.The customer was issued with a replacement non-return valve (nrv) and top case as part of a warranty claim.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an astral device had an unresponsive touchscreen and 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 not returned to resmed.An investigation was performed on all available information.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the unresponsive touchscreen was due to a software issue while the failure to complete its internal self-test was due to a faulty/defective nrv.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: pr 2239014.

Event Description

It was reported to resmed that an astral device had an unresponsive touchscreen and failed to complete its internal self-test.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - FUKUDA
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11507411
• MDR Text Key: 243131083
• Report Number: 3004604967-2021-00404
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270934
• UDI-Public: (01)00619498270934(10)1431751
• Combination Product (y/n): N
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27093
• Device Catalogue Number: 27093
• Device Lot Number: 1431751
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/14/2021
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1