ICS CHARTR 200

Additional Manufacturer Narrative

(B)(6) 2019: INVESTIGATION INTO THE ROOT CAUSE IS ONGOING.

Description of Event or Problem

THE 1.6 A FUSE OF CHARTR 200 WAS BURNED.

Additional Manufacturer Narrative

INVESTIGATION RESULTS & FINDINGS PRODUCT EXAMINATION AND FUNCTIONAL TESTING: PRODUCT EXAMINATION AND TESTING PERFORMED BY NATUS FACTORY SERVICE. THE ISSUE AS REPORTED WAS CONFIMRED. THE REPAIRED DEVICE WAS SHIPPED. A REVIEW OF CAPAS INDICATED THAT THERE ARE NO CAPAS RELATED TO THIS ISSUE. COMPLAINTS REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. THE CURRENT RISK FILE DOES NOT HAVE A CORRESPONDING RISK IDENTIFIED HOWEVER A RISK REVIEW WAS CONDUCTED AND DOCUMENTED IN DOC-043316 WHICH LISTS THE POTENTIAL HAZARD OF DELAY IN TREATMENT OR DIAGNOSIS, OR PATIENT DISCOMFORT DUE TO DEVICE NOT AVAILABLE FOR USE - HARM - DELAY IN TREATMENT OR DIAGNOSIS, OR PATIENT DISCOMFORT CAUSE- DEVICE NOT AVAILABLE FOR USE - ELECTRICAL COMPONENT FAILURE (E.G., BAD SWITCH, BLOWN FUSE, BURNED-OUT HEATING ELEMENT / LAMP, FAN / BLOWER NOT WORKING, BENT PINS / BROKEN CONNECTOR, ETC.) SEVERITY- NEGLIGIBLE (0) RISK LEVEL- MINOR (0) A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. DHR REVIEW - DOCUMENT NUMBER 60-54-0118 (B)(6)2017 REVIEWED AND PRODUCT PASSED ALL TESTS ACCORDING TO THE CONTRACTED MANUFACTURER. A SEARCH FOR SERVICE DATA THAT MAY BE RELEVANT TO THIS ISSUE HAS BEEN CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS ISSUE FOUND. THIS ISSUE WILL BE CONTINUED TO BE MONITORED.

Additional Manufacturer Narrative

UPDATE (B)(6)2020 INVESTIGATION INCOMPLETE TO DATE. INVESTIGATION PENDING.

Description of Event or Problem

THE 1.6 A FUSE OF CHARTR 200 WAS BURNED.

Additional Manufacturer Narrative

UPDATE 17TH JANUARY 2020 UPDATE 17TH JANUARY 2020: ROOT CAUSE INVESTIGATION PLAN HAS BEEN DEVISED. ESTIMATED COMPLETION DATE FOR ROOT CAUSE IS (B)(6) 2020.

Additional Manufacturer Narrative

A REPAIR AND RETURN WILL BE COMPLETED BUT AT THIS TIME TECH SUPPORT DOES NOT HAVE PARTS TO REPLACE THE MAIN UNIT. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PATIENT INFORMATION - NO PATIENT INVOLVEMENT. RELEVANT TESTS / LABORATORY DATA - THIS IS NOT APPLICABLE AS NO PATIENT INJURY REPORTED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY REPORTED. LOT # - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A LOT NUMBER. UDI - NOT KNOW AT THE TIME OF THIS REPORT. EXPIRATION DATE - DEVICE HAS NO RESTRICTED SHELF LIFE. IF IMPLANTED DATE (MM/DD/YYYY) - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT) - THIS IS NOT APPLICABLE TO THIS TYPE OF DEVICE. FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. IF ND, GIVE PROTOCOL # - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. MANUFACTURE DATE - INFORMATION NOT AVAILABLE AT THE TIME OF THE REPORT THIS WILL BE SUBMITTED IN THE FOLLOW UP REPORT. ADVERSE EVENT TERMS - THIS IS NOT APPLICABLE TO MEDICAL DEVICES. IF REMEDIAL ACTION INITIATED , CHECK TYPE - THIS IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I (F), LIST CORRECTION / REMOVAL REPORTING NUMBER - THIS IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).

Description of Event or Problem

THE 1.6 A FUSE OF CHARTR 200 WAS BURNED. CHARTR 200, 1068 SN (B)(4). USER STATES: "ONE DAY WE WANTED TO TURN ON THE EQUIPMENT AND WE FOUND AFTER CHECKING THE POWER SOURCE AND ISOLATION TRANSFORMER, THAT THE 1.6 A FUSE OF CHARTR 200 WAS BURNED. WE PROCEEDED TO THE REPLACEMENT AND EVERYTHING BEGAN TO WORK CORRECTLY, BUT AFTER 10 TO 15 MINUTES OF IGNITION, A BURNING ODOR BEGAN TO EMERGE FROM THE EQUIPMENT, SO WE OPENED IT TO FIND THE CAUSE AND DETECTED THAT THE DIODE D69 (C48 LPC ) WAS BURNING. " THIS INCIDENT OCCURRED DURING EQUIPMENT OPERATION CHECK.

Additional Manufacturer Narrative

(B)(6)2019 UPDATE: DEVICE RECEIVED BACK ON THE 24TH OF OCTOBER FOR EVALUATION AND REPAIR.

Additional Manufacturer Narrative

(B)(6)2019 : THE REPAIR IS RECEIVED IN THE TAASTRUP DEPOT REPAIR, BUT HASN´T BEEN PROCESSED YET DUE TO MISSING SPARE PARTS.

Additional Manufacturer Narrative

WAITING FOR THE RETURN OF THE DEVICE TO COMPLETE A FURTHER EVALUATION.