VITAL SYNC

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.

Description of Event or Problem

ACCORDING TO THE REPORTER, PRIOR TO USE, MULTIPLE TILES HAD MULTIPLE PATIENTS ADMITTED TO THEM AND ALARMS FOR THE CURRENT PATIENT DID NOT ALERT ON THE TILE DUE TO MANY PATIENTS AND THE ALARMS WERE GETTING PUSHED OUT OF THE TILE. IT WAS FOUND OUT THAT PATIENTS WERE NOT GETTING DISCHARGE FROM THE REMOTE SURVEILLANCE SYSTEM BEFORE NEW PATIENT WAS ADMITTED. AN INTERNAL STAFF WAS ON THE SITE AND PATIENTS THAT WERE ASSIGNED TO THE SAME TILE WERE DISCHARGED. THERE WAS NO PATIENT INVOLVEMENT.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING USE, MULTIPLE TILES HAD MULTIPLE PATIENTS ADMITTED TO THEM AND ALARMS FOR THE CURRENT PATIENT DID NOT ALERT ON THE TILE DUE TO MANY PATIENTS AND THE ALARMS WERE GETTING PUSHED OUT OF THE TILE. IT WAS FOUND OUT THAT PATIENTS WERE NOT GETTING DISCHARGE FROM THE REMOTE SURVEILLANCE SYSTEM BEFORE NEW PATIENT WAS ADMITTED. AN INTERNAL STAFF WAS ON THE SITE AND PATIENTS THAT WERE ASSIGNED TO THE SAME TILE WERE DISCHARGED. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

NEW INFORMATION HAS BEEN RECEIVED, AND REASSESSMENT OF THE COMPLAINT FOUND THAT IT IS NO LONGER A REPORTABLE EVENT. THE EVENT IS NO LONGER ASSOCIATED WITH A SERIOUS INJURY OR POTENTIAL FOR SERIOUS INJURY WITH REOCCURRENCE. 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: H6 CORRECTION: G3 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.