RAD-8
Received May 4, 2017 · Event occurred Apr 17, 2017
Report 2031172-2017-00542 · MDR key 6546273
Device
Product problems
- Inappropriate or Unexpected Reset
- Inappropriate or Unexpected Reset
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE RETURNED DEVICE WAS EVALUATED WHICH INCLUDED FUNCTIONAL TESTING. DURING THIS TESTING THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. INTERNAL INSPECTION OF THE DEVICE INDICATED THE BATTERY DOES NOT HOLD THE MINIMUM ACCEPTABLE CHARGE CAPACITY. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER ONE (1) YEAR WITH NO PREVIOUS REPORTED ISSUES RELATED TO THIS REPORTED EVENT.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THIS DEVICE SHUTS ITSELF OFF AFTER SOME TIME OF BEING POWERED ON. THE DEVICE IS ABLE TO ENGAGE IN MONITORING. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Remedial action
- Other