MASTERSCREEN
Received Jul 31, 2020 · Event occurred Jul 1, 2020
Report 9615102-2020-00114 · MDR key 10353884
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. THE REPLACEMENT FOR SYSTEM BOX AND PAED CONTROLLER WAS ALREADY SENT TO THE CUSTOMER.
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MASTERSCREEN DEVICE WAS FOUND TO HAVE A BURNED CIRCUIT BOARD PARTS INSIDE THE SYSTEM BOX WHEN THEY TURNED ON THE POWER DURING INSTALLATION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.