MCGRATH MAC

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT DURING TESTING, THE DISPLAY OF A VIDEOLARYNGOSCOPE BLANKED OUT WHEN TILTED IN ANY DIRECTION, ALTHOUGH THE LIGHT REMAINED ON. TROUBLESHOOTING STEPS INCLUDED CHECKING IF THE BATTERY WAS REPLACED OR EXCHANGED, AND POWERING THE DEVICE OFF AND ON, BUT THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVED.