MAUDE Adverse Event Report: RESMED LTD PNEUMATIC BLOCK ASSY - ASTRAL

Model Number 19623

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/18/2021

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 failed resmed service 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.Performance testing confirmed the reported complaint.Visual inspection of the disassembled pneumatic block revealed contamination.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to an isolated component failure within the pneumatic block.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 resmed service test.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: PNEUMATIC BLOCK ASSY - ASTRAL
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11506747
• MDR Text Key: 241965526
• Report Number: 3007573469-2021-00395
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498196234
• UDI-Public: (01)00619498196234(10)1475639
• 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: 09/09/2021

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: 19623
• Device Catalogue Number: 19623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2021
• Distributor Facility Aware Date: 08/16/2021
• Device Age: 6 MO
• Date Report to Manufacturer: 09/09/2021
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1