MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - DEU

Model Number 27053

Device Problems Failure to Power Up (1476); Inadequate User Interface (2958); Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015); Complete Loss of Power (4015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed for an 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.(b)(4).Pending evaluation.

Event Description

It was reported to resmed that an astral device had an unresponsive, dark screen with intermittent visual and audible alarms and could not be restarted.The device was replaced with a second device.There was no patient harm or an adverse event reported as a result of this incident.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs revealed error messages (sf74) related to the software and total power failure alarms followed by safety reset complete alarms.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the total power failure alarms were due to an intermittent connection of the battery while the safety reset complete alarms and sf74 were due to an intermittent connection of the expiratory flow sensor.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 had an unresponsive, dark screen with intermittent visual and audible alarms and could not be restarted.The device was replaced with a second device.There was no patient harm or an adverse event reported as a result of this incident.

• Brand Name: ASTRAL 150 - DEU
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9964657
• MDR Text Key: 188276898
• Report Number: 3004604967-2020-00495
• Device Sequence Number: 1
• Product Code: CBK
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27053
• Device Catalogue Number: 27053
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/27/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1