ASTRAL 100 - EUR4
Received Feb 25, 2022 · Event occurred Jan 14, 2022
Report 3007573469-2022-00118 · MDR key 13601817
Device
Product problems
- No Display/Image
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE 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. RESMED REFERENCE #: (B)(4).
Description of Event or Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF192) RELATED TO POWER TO SENSOR BOARD. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Description of Event or Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF192) RELATED TO POWER TO SENSOR BOARD. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Additional Manufacturer Narrative
THE ASTRAL DEVICE WAS RETURNED TO RESMED FOR AN INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS AND PERFORMANCE TESTING CONFIRMED THE REPORTED COMPLAINT. VISUAL INSPECTION OF THE SENSOR CIRCUIT BOARD REVEALED A DEFECTIVE SOLDER JOINT. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO SOLDERING PROCESS DURING MANUFACTURING. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).