MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER

Model Number 27003

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Protective Measures Problem (3015)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint.The internal battery was replaced to address this issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference #: (b)(4).

Event Description

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

Event Description

It was reported to resmed that an astral device had an internal battery with a reduced level of capacity, displayed a battery error message, did not power up without connected to ac and battery is not charging.The device was not in patient use when the reported event occurred.

Manufacturer Narrative

Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint 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).

• Brand Name: ASTRAL 150 - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 12257245
• MDR Text Key: 266370907
• Report Number: 3004604967-2021-00834
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)200630(10)1465348
• Combination Product (y/n): N
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

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: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Distributor Facility Aware Date: 09/23/2021
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/31/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1