MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - FUKUDA

Model Number 27093

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Performance testing could not reproduce the reported complaint and review of the device data logs could not confirm the reported complaint.No parts were replaced to address the reported problem.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.The initial medwatch report was submitted in error under a previous single mdr exemption approval, this resubmission is done to correct the error.Previously submitted medwatch report number 3004604967-2019-00211 / 3007573469-2019-00211.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an astral device displayed a warning alarm related to occlusion of the expiratory port.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 ; AU 2153
• MDR Report Key: 11047670
• MDR Text Key: 241254633
• Report Number: 3007573469-2020-01212
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JP
• 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: 12/21/2020

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: 27093
• Device Catalogue Number: 27093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2020
• Distributor Facility Aware Date: 06/21/2019
• Device Age: 24 MO
• Date Report to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1