ASTRAL 100 - AMER
Received Nov 19, 2021 · Event occurred Sep 30, 2021
Report 3004604967-2021-01173 · MDR key 12849218
Device
Product problems
- Battery Problem
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional 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. 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).
Description of Event or Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN INTERNAL BATTERY DEGRADED WARNING ALARM. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.