MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL 150 - APAC; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27083

Device Problems Failure to Power Up (1476); Power Problem (3010)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an investigation can be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.Resmed reference #: pr (b)(4).

Event Description

It was reported to resmed that an astral device failed to charge its internal battery when connected to mains power and did not power up.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 failed to charge its internal battery when connected to mains power and did not power up.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was returned to a third party service center.An evaluation was unable to confirm the reported complaint.Visual inspection of the dc power plug revealed it was bent.Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to a physically damaged dc power plug.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

• Brand Name: ASTRAL 150 - APAC
• 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: 19035269
• MDR Text Key: 339292177
• Report Number: 3007573469-2024-00090
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270835
• UDI-Public: (01)00619498270835(10)1443360
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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: 27083
• Device Catalogue Number: 27083
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2024
• Distributor Facility Aware Date: 04/21/2024
• Device Age: 47 MO
• Date Report to Manufacturer: 05/08/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/21/2024
• Supplement Dates FDA Received: 05/08/2024
• Date Device Manufactured: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1