MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER

Model Number 27003

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591); Protective Measures Problem (3015); Temperature Problem (3022)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint.The main circuit board and pneumatic block were replaced to address this issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference #: pr (b)(4).

Event Description

It was reported to resmed that an astral device displayed an error message (sf131) related to the main blower temperature sensor.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 displayed an error message (sf131) related to the main blower temperature sensor and had an internal battery with a reduced level of capacity.The device was not in patient use when the reported event occurred.

Manufacturer Narrative

During evaluation, the reported internal battery with a reduced level of capacity could not be confirmed.Visual inspection of the device revealed a black substance within the device.Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported sf131was due to contamination of the device.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

• Brand Name: ASTRAL 150 - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11728798
• MDR Text Key: 249685921
• Report Number: 3007573469-2021-00536
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)200816(10)1474735
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2021
• Distributor Facility Aware Date: 07/12/2021
• Device Age: 7 MO
• Date Report to Manufacturer: 08/10/2021
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1