EQUIPMENT RACK 9734061 I7 220V

Report

Report Number: 1723170-2019-02909
Event Type: Malfunction
Date Received: June 4, 2019
Date of Event: May 8, 2019
Report Date: September 1, 2020
Manufacturer: MEDTRONIC NAVIGATION, INC
Product Code: HAW
PMA / PMN Number: K050438
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

CONTINUATION OF D11: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 735226R, (COMPUTER) LOT/SERIAL #: (B)(6), (TRANSCEIVER) LOT/SERIAL #: (B)(6), (TRANSCEIVER) LOT/SERIAL #: (B)(6), (I/O HUB) LOT/SERIAL (B)(6), (RELAY) LOT/SERIAL #: (B)(6), (TRANSCEIVER) LOT/SERIAL #: (B)(6), (SCU) LOT/SERIAL #: (B)(6), (TRANSCEIVER) LOT/SERIAL #: (B)(6), H3) THE COMPUTER WAS RETURNED TO THE MANUFACTURE FOR EVALUATION. AFTER FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION THE REPORTED ISSUE WAS CONFIRMED. THE COMPUTER BOOTS NORMALLY TO THE APPLICATION SCREEN. THE ENT PROGRAM WAS UNRESPONSIVE. A TEST CAMERA STAYED CONNECTED DURING AN 8 HOUR BURN-IN TEST. THE COMPUTER FAILED THE VESA RAM TEST IN PHD. THE COMPUTER HAD A BAD VIDEO CARD AND A FAILING HARD DRIVE. EVAL CODE METHOD 10 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE RESULT 180 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE CONCLUSION 4307 IS ASSOCIATED WITH THIS ANALYSIS THE TRANSCEIVER WAS RETURNED TO THE MANUFACTURE FOR EVALUATION. AFTER FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION THE REPORTED ISSUE WAS CONFIRMED. THE TRANSCEIVER HAD SHIPPING DAMAGE AND COULD NOT BE TESTED. EVAL CODE METHOD 10 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE RESULT 180 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE CONCLUSION 4307 IS ASSOCIATED WITH THIS ANALYSIS THE TRANSCEIVER WAS RETURNED TO THE MANUFACTURE FOR EVALUATION. AFTER FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION THE REPORTED ISSUE WAS NOT CONFIRMED. THE TRANSCEIVER WAS RECEIVED WITH A NOTE THAT IT WAS UNUSED, HOWEVER THE TAPE WAS CUT AND THE PROTECTIVE PLUGS FOR THE FIBER PORTS WERE MISSING INDICATING THAT IT WAS USED. UNIT WAS TESTED AND FOUND TO FUNCTION AS EXPECTED. EVAL CODE METHOD 10 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE RESULT 213 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE CONCLUSION 67 IS ASSOCIATED WITH THIS ANALYSIS THE I/O HUB WAS RETURNED TO THE MANUFACTURE FOR EVALUATION. AFTER FUNCTIONAL TESTING, VISUAL/PHYSICAL EXAMINATION AND PROCEDURALIZED DEVICE TESTING THE REPORTED ISSUE WAS NOT CONFIRMED. THE I/O HUB WAS TESTED ON BENCH TESTER AND PASSED TESTING. NO FAILURE FOUND. EVAL CODE METHOD 10 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE RESULT 213 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE CONCLUSION 67 IS ASSOCIATED WITH THIS ANALYSIS THE RELAY WAS RETURNED TO THE MANUFACTURE FOR EVALUATION. AFTER FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION THE REPORTED ISSUE WAS NOT CONFIRMED. THE RELAY WAS TESTED AND WORKED AS EXPECTED. NO POWER WAS APPLIED WHEN THE SWITCH WAS OPEN, WHEN CLOSED POWER WAS PROVIDED TO THE PLUGS. NO FAILURE WAS FOUND. EVAL CODE METHOD 10 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE RESULT 213 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE CONCLUSION 67 IS ASSOCIATED WITH THIS ANALYSIS THE TRANSCEIVER WAS RETURNED TO THE MANUFACTURE FOR EVALUATION. AFTER FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION THE REPORTED ISSUE WAS NOT CONFIRMED. THE TRANSCEIVER WAS TESTED FOR OVER 24 HOURS WITHOUT USB COMMUNICATION DISRUPTION. IMAGE WAS DISPLAYED AND TOUCH FUNCTION WAS WORKING AS EXPECTED. NO FAILURE FOUND. EVAL CODE METHOD 10 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE RESULT 213 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE CONCLUSION 67 IS ASSOCIATED WITH THIS ANALYSIS THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) WAS RETURNED TO THE MANUFACTURE FOR EVALUATION. AFTER FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION THE REPORTED ISSUE WAS NOT CONFIRMED. THE RETURNED SCU WAS FOUND TO BE FULLY FUNCTIONAL WHEN CONNECTED TO A KNOWN GOOD SYSTEM. A CHECK OF THE EVENT LOG DID NOT SHOW ANY ADVERSE EVENTS. NO PROBLEM FOUND. THIS SCU HAS NOT BEEN PREVIOUSLY RETURNED FOR A FAILURE. EVAL CODE METHOD 10 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE RESULT 213 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE CONCLUSION 67 IS ASSOCIATED WITH THIS ANALYSIS THE TRANSCEIVER WAS RETURNED TO THE MANUFACTURE FOR EVALUATION. AFTER FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION THE REPORTED ISSUE WAS NOT CONFIRMED. THE TRANSCEIVER WAS TESTED FOR OVER 24 HOURS WITHOUT USB COMMUNICATION DISRUPTION. IMAGE WAS DISPLAYED AND TOUCH FUNCTION WAS WORKING AS EXPECTED. NO FAILURE WAS FOUND. EVAL CODE METHOD 10 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE RESULT 213 IS ASSOCIATED WITH THIS ANALYSIS EVAL CODE CONCLUSION 67 IS ASSOCIATED WITH THIS ANALYSIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.