MAUDE Adverse Event Report: RESMED PTY LTD PNEUMATIC BLOCK ASSY - ASTRAL; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 19623

Device Problem Protective Measures Problem (3015)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to resmed.The investigation methods, results, and conclusions are not finalized at this stage.If further information becomes available, a supplementary report will be submitted.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device displayed an error message (sf147) related to the main blower.The device was not in patient use when the reported event occurred.

Manufacturer Narrative

The device was returned to a third party service center for an evaluation and service.The customer was issued with a replacement pneumatic block as part of a warranty claim.Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to a detached blower cable during manufacturing.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 (sf147) related to the main blower.The device was not in patient use when the reported event occurred.

• Brand Name: PNEUMATIC BLOCK ASSY - ASTRAL
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 18414730
• MDR Text Key: 331581629
• Report Number: 3007573469-2023-00705
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498196234
• UDI-Public: (01)00619498196234(10)1705760
• 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
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 19623
• Device Catalogue Number: 19623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2023
• Distributor Facility Aware Date: 12/01/2023
• Device Age: 6 MO
• Date Report to Manufacturer: 12/28/2023
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1