ELITE AUTO SHUT-OFF 200R MAIN

Additional Manufacturer Narrative

UPDATE 09TH APRIL 2020. INVESTIGATION RESULTS & FINDINGS (NATUS COMPLAINT REF. #: (B)(4)): PRODUCT EXAMINATION AND FUNCTIONAL TESTING: PRODUCT RECEIVED IN HOUSE ON FEBRUARY 26, 2020. EVALUATED BY (B)(4) ON MARCH 03, 2020, DEPOT REPAIR CONFIRMED PROBE HAD NO SIGNAL. CAPA TRENDING REVIEW: THERE ARE NO CAPA'S RELATED TO THIS ISSUE AND THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. COMPLAINT TRENDING REVIEW: PER (B)(4) COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED. RISK MANAGEMENT FILE REVIEW: BASED ON ADVERSE EVENT REPORTING REVIEW FORM FOUND IN THE ATTACHMENTS TAB, PER (B)(4), HAZARD ID - 5.32, SEVERITY - 3, RISK - MODERATE. SERVICE RECORD REVIEW: SERVICE REPAIR INVESTIGATIONS WILL BE CONDUCTED DURING THE REPAIR PROCESS AND TREND DATA WILL BE REVIEWED PER (B)(4). THIS ISSUE WILL BE CONTINUED TO BE MONITORED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY ARE UNABLE TO HEAR HEARTRATE OR BLOOD FLOW ULTRASOUNDS WHEN USING THE PROBE AND ELITE 200R. CUSTOMER ONLY HEARS WHITE NOISE AND STATIC.

Additional Manufacturer Narrative

UPDATE 07TH MAY 2020 (NATUS COMPLAINT REF. # (B)(4) INVESTIGATION RESULTS & FINDINGS CUSTOMER COMPLAINT CONFIRMED AS PROBE HAVING NO SIGNAL. THE ROOT CAUSE OF THE FAILURE MODE COULD NOT BE ESTABLISHED. THE COMPLAINT WAS VERIFIED, RESOLVED ON-SITE AND NO FURTHER ACTION IS NECESSARY. THIS COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF REQUIRED. THIS ISSUE WILL BE CONTINUED TO BE MONITORED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY ARE UNABLE TO HEAR HEARTRATE OR BLOOD FLOW ULTRASOUNDS WHEN USING THE PROBE AND ELITE 200R. CUSTOMER ONLY HEARS WHITE NOISE AND STATIC.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THEY ARE UNABLE TO HEAR HEARTRATE OR BLOOD FLOW ULTRASOUNDS WHEN USING THE PROBE AND ELITE 200R. CUSTOMER ONLY HEARS WHITE NOISE AND STATIC. A COMPLAINT FORM WAS SENT TO THE CUSTOMER TO GAIN MORE INFORMATION. THE CUSTOMER HAS COMPLETED THIS FORM AND RETURNED TO NATUS. IT CONFIRMED THAT THERE WAS NO PATIENT INJURY. CUSTOMER BELIEVES INCIDENT OCCURRED DURING A PRENATAL CHECKUP. A REQUEST WAS MADE TO HAVE THE DEVICE RETURNED FOR INVESTIGATION. THE DEVICE HAS BEEN RECEIVED AT DEPOT REPAIR WHERE INVESTIGATION WILL TAKE PLACE. THIS INVESTIGATION IS NOT YET COMPLETE. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PATIENT INFORMATION: NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED. DATE OF EVENT: DATE OF EVENT REQUESTED FROM THE CUSTOMER BUT INFORMATION NOT YET PROVIDED. RELEVANT TESTS / LABORATORY DATA : THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. SUSPECT PRODUCTS: NOT APPLICABLE. SERIAL #: THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A SERIAL NUMBER. IF IMPLANTED DATE (MM/DD/YYYY): THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY): THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS: THIS SECTION 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 SECTION 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 SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS: THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. IF REMEDIAL ACTION INITIATED , CHECK TYPE: THIS SECTION 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 SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY ARE UNABLE TO HEAR HEARTRATE OR BLOOD FLOW ULTRASOUNDS WHEN USING THE PROBE AND ELITE 200R. CUSTOMER ONLY HEARS WHITE NOISE AND STATIC.