MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - FUKUDA

Model Number 27093

Device Problems Failure to Run on Battery (1466); Protective Measures Problem (3015)

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

Event Date 02/16/2021

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 displayed a power loss alarm when ac power was disconnected.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 and revealed the device would not power on while using its internal battery.Review of the device data logs revealed occurrences of an error message (sf180) related to a battery charger fault.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the sf180 was due to an isolated component failure within the device battery assembly.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 a power loss alarm when ac power was disconnected.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 ; AS 2153
• MDR Report Key: 11485851
• MDR Text Key: 243131023
• Report Number: 3004604967-2021-00390
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270934
• UDI-Public: (01)00619498270934(10)1447912
• Combination Product (y/n): N
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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?: Yes
• Distributor Facility Aware Date: 05/25/2021
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1