HMS PLUS INSTRUMENT

Additional Manufacturer Narrative

DEVICE EVALUATION: THE REPORTED ISSUE OF NOT PASSING NORMAL LIQUID QUALITY CONTROL (QC) CONSISTENTLY WAS NOT VERIFIED DURING SERVICE. SERVICE TECHNICIAN WAS UNABLE TO FIND ANY ERRORS WITH HMS. INSTRUMENT TO BE SENT TO THE SERVICE DEPOT FOR FURTHER EVALUATION. 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

MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT IT WAS NOT PASSING NORMAL LIQUID QUALITY CONTROL (QC) CONSISTENTLY. THE INSTRUMENT FAILED 3 OUT OF 10 TIMES. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.