MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 DBL KIT FRA

Model Number 27074

Device Problems Unintended Ejection (1234); Failure to Run on Battery (1466); Battery Problem (2885); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint.The internal battery and pcb were replaced to address the issues.The device was serviced and fully tested before it was returned to the customer.(b)(4).

Event Description

It was reported to resmed that an astral device displayed a battery error message and the pcb had capacitor leakage.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.Review of the device data logs confirmed the reported battery error message and revealed an internal battery degraded warning alarm and 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 battery error message, sf180 and internal battery degraded warning alarm were 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#: pr 2167255.

Event Description

It was reported to resmed that an astral device displayed a battery error message and the main circuit board had a leaky super capacitor.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 DBL KIT FRA
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11062055
• MDR Text Key: 224598000
• Report Number: 3004604967-2020-01252
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27074
• Device Catalogue Number: 27074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2020
• Distributor Facility Aware Date: 01/17/2021
• Date Manufacturer Received: 01/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1