MAUDE Adverse Event Report: RESMED LTD ASTRAL BATTERY PACK

Model Number 19620

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

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).Device evaluated by manufacturer? pending evaluation.

Event Description

It was reported to resmed that an astral device had an internal battery with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was not returned to resmed.An investigation was performed on all available information.Review of the device data logs revealed internal battery degraded warning alarms.The customer was issued a replacement internal battery as part of a warranty claim.Based on all available evidence and complaint investigations of a similar nature, the 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).

Event Description

It was reported to resmed that an astral device had an internal battery with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL BATTERY PACK
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9635225
• MDR Text Key: 188546011
• Report Number: 3004604967-2020-00204
• 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: 10/01/2021

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: 19620
• Device Catalogue Number: 19620
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/08/2020
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1