BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY,FA,RC3,ROHS

    MDR report key: 11861586 · Received May 21, 2021

    Report

    Report Number
    3010611950-2021-00002
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 10, 2021
    Manufacturer
    NATUS NEUROLOGY INCOPORATED
    Product Code
    HKI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT # (B)(4). (B)(6) 2021: AFFECTED PART 21-100665 SN (B)(6) HAS BEEN RECEIVED IN MIDDLETON FOR EVALUATION. AWAITING EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT # (B)(4). THE FA MODULE ON THE RETCAM SYSTEM (RETCAM 3 SN: (B)(4)) HAS FAILED. THE CUSTOMER HEARD A LOUD POP AND THEN SMELLED SMOKE AFTER ENGAGING THE UNIT. THE DISTRIBUTOR REMOVED THE AFFECTED FA UNIT PART 21-100665 SN (B)(4) FROM THE MACHINE AND NOTED THAT THE FANS WERE NOT SPINNING, IT APPEARS THE POWER SUPPLY HAS BLOWN. THERE WAS A PATIENT INVOLVED, THE EVENT OCCURRED WHILE THE PATIENT WAS ON THE OPERATION TABLE AND ALREADY ANAESTHETIZED. THE SURGEON WAS ABOUT TO PROCEED WITH FFA WHEN THE EVENT OCCURRED. THERE WAS DELAY IN TREATMENT. THE CUSTOMER WAS UNABLE TO DO AN FFA, WHICH WAS CRITICAL TO DETERMINE NEXT TREATMENT STEPS (LASER AND/OR INJECTION), WHICH WOULD HAVE OCCURRED RIGHT AFTER THE FFA IF NEEDED, WITH THE SAME ANESTHETIC. THERE WAS ENVIRONMENTAL/SAFETY CONCERNS. THE DOCTOR STATED THAT "THERE WAS A BIG EXPLOSION NOISE FROM THE MACHINE, THEN A STRONG SMELL OF ELECTRICAL WIRE BEING BURNED." THERE WAS NO DEATH OR SERIOUS INJURY. THE PATIENT WAS FINE. (B)(6) 2021: TECHNICAL SERVICE ASKED THE DISTRIBUTOR TO MAKE SURE THE SYSTEM HAS BEEN TAKEN OUT OF SERVICE UNTIL THE FA FAILURE (PART 21-100665 SN (B)(4)) CAN BE INVESTIGATED. 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. PER QMS-004442 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. PER RISK ASSESSMENT_18-000022 REV R, RISK ASSESSMENT RETCAM, REF. LINE 9.1.5, THE RISK IS CONSIDERED ACCEPTABLE. 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. A DEVICE HISTORY RECORD REVIEW IS NOT APPLICABLE BECAUSE, PRIOR TO THE REPORTED ISSUE THE DEVICE WAS IN SERVICE FOR 2 OR MORE YEARS AND A MANUFACTURING DEFECT IS VERY UNLIKELY. AFFECTED PART 21-100665 SN (B)(4) HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF NATUS COMPLAINT # (B)(4). PRODUCT EXAMINATION: THE FA UNIT WAS RETURNED TO MIDDLETON. INVESTIGATION CONDUCTED BY DEPOT REPAIR. REPAIR FOUND THAT "ONE OF THE 8A 250V FUSE ON THE POWER SUPPLY WAS OPENED DUE TO A SHORT CIRCUIT. THEY INSPECTED BOTH THE LAMP ASSY BOARD AND THE MAIN PCB FOR BLOWN UP CAPACITORS BUT DID NOT FIND ANY. THE PART # OF THE FUSE IS 18-000496." "FAILURE" CONFIRMED: YES. 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. PER QMS-004442 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. PER RISK ASSESSMENT_18-000022 REV R, RISK ASSESSMENT RETCAM, REF. LINE 9.1.5, THE RISK IS CONSIDERED ACCEPTABLE. 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. A DEVICE HISTORY RECORD REVIEW IS NOT APPLICABLE BECAUSE, PRIOR TO THE REPORTED ISSUE THE DEVICE WAS IN SERVICE FOR 2 OR MORE YEARS AND A MANUFACTURING DEFECT IS VERY UNLIKELY.

    Description of Event or Problem · 0

    FA FAILED. THE CUSTOMER HEARD A LOUD POP AND THEN SMELLED SMOKE AFTER ENGAGING THE UNIT. THERE WAS A DELAY IN TREATMENT. THERE WAS NO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    FA FAILED. THE CUSTOMER HEARD A LOUD POP AND THEN SMELLED SMOKE AFTER ENGAGING THE UNIT. THERE WAS A DELAY IN TREATMENT. THERE WAS NO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    FA FAILED. THE CUSTOMER HEARD A LOUD POP AND THEN SMELLED SMOKE AFTER ENGAGING THE UNIT. THERE WAS A DELAY IN TREATMENT. THERE WAS NO DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761177 ASSY,FA,RC3,ROHS ASSY,FA,RC3,ROHS HKI NATUS NEUROLOGY INCOPORATED 21-100665

    Patients

    Seq Age Sex Outcome Treatment
    1