MalfunctionLEJ
ASTRAL 150 - APAC1
Received Mar 18, 2022 · Event occurred Feb 16, 2022
Report 3007573469-2022-00179 · MDR key 13812268
Device
Product problems
- Defective Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION CONFIRMED THE COMPLAINT. THE POWER SUPPLY UNIT WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED REFERENCE #: (B)(4).
Description of Event or Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL POWER SUPPLY UNIT (PSU) WAS INOPERABLE. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.