MCGRATH MAC

Description of Event or Problem

IT WAS REPORTED THAT DURING INTUBATION, THE VIDEOLARYNGOSCOPE DID NOT SWITCH ON PROPERLY. A BLUE LOADING SCREEN WITH MULTIPLE CHARGING POINTS WAS VISIBLE, FOLLOWED BY A BLACK SCREEN, THE BATTERY LEVEL INDICATED EMPTY, AND THE VIDEOLARYNGOSCOPE WAS NOT READY FOR USE. A FURTHER ATTEMPT TO START THE VIDEOLARYNGOSCOPE ALSO FAILED. ON THE SECOND ATTEMPT, THE VIDEOLARYNGOSCOPE FREEZES ON THE LOADING SCREEN, AND THE CAMERA IMAGE WAS NEVER VISIBLE ON THE SCREEN. ABOUT 30 MINUTES AFTER THE OPERATION, ANOTHER TEST WAS CARRIED OUT, THIS TIME THE VIDEOLARYNGOSCOPE STARTED UP CORRECTLY WITH A BATTERY LEVEL INDICATOR OF 86%. NO PATIENT HARM WAS CAUSED BY HAVING A SPARE VIDEOLARYNGOSCOPE DURING THE OPERATION.

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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THE VIDEOLARYNGOSCOPE DID NOT SWITCH ON PROPERLY. A BLUE LOADING SCREEN WITH MULTIPLE CHARGING POINTS WAS VISIBLE, FOLLOWED BY A BLACK SCREEN, THE BATTERY LEVEL INDICATED EMPTY, AND THE VIDEOLARYNGOSCOPE WAS NOT READY FOR USE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.