BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1068 ICS CHARTR 200 VNG INCL. LIGHTBAR LB-200 AND VIDEO GOOGLE VG40

    MDR report key: 11782433 · Received May 6, 2021

    Report

    Report Number
    9612197-2021-00007
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 15, 2021
    Report Date
    August 24, 2021
    Manufacturer
    NATUS MEDICAL DENMARK APS
    Product Code
    GWN
    PMA / PMN Number
    K061791
    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).) AWAITING RETURN OF ALL COMPONENTS OF THE DEVICE FOR EVALUATION, REF PART 8-35-24201 LOT / SERIAL (B)(6) . NO COMPONENTS RETURNED TODATE. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. COMPLAINTS ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS (QMS-004442 CORPORATE TRENDING AND ANALYSIS PROCEDURE ) AND ANY COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW DOC- 054330. NO TREND FOR THIS DEVICE IDENTIFIED 1068 RISK ANALYSIS DOC 7-38-00101 REV 07 WAS REVIEWED: POSSIBLE ENERGY HAZARDS AND CONTRIBUTION FACTORS: 1.ELECTRICITY THE TYPE 1068 SYSTEM HARDWARE CONTAINS HAZARDOUS VOLTAGES THAT MIGHT CAUSE ELECTRIC SHOCK AND FIRE. RISK ESTIMATION: LIKELIHOOD: OCCASIONAL, SEVERITY: CRITICAL RISK REDUCTION: THE TYPE 1068 SYSTEM IS DESIGNED TO COMPLY WITH REQUIREMENTS IN EN 60601-1 AND EN 60601-2-40 FOR MAINS CONNECTED EQUIPMENT WITHOUT PROTECTIVE EARTH. CONCLUSION: THE RISK IS ACCEPTABLE WHEN TYPE 1068 SYSTEM COMPLIES WITH ABOVE-MENTIONED STANDARDS. 2.HEAT FROM THE TYPE 1068 SYSTEM HARDWARE MIGHT CAUSE FIRE AND BURNS. RISK ESTIMATION: LIKELIHOOD: OCCASIONAL, SEVERITY: CRITICAL RISK REDUCTION: THE TYPE 1068 SYSTEM HARDWARE IS DESIGNED TO COMPLY WITH EN 60601-1 CONCLUSION: THE RISK IS ACCEPTABLE WHEN TYPE 1068 SYSTEM COMPLIES WITH EN 60601-1.S 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.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 003 (REF NATUS COMPLAINT #(B)(4)). DEVICE AND ALL COMPONENTS OF THE DEVICE WERE RECEIVED FOR EVALUATION (PART 8-35-24201 LOT / SERIAL (B)(6). FAILLURE CONFIRMED: YES, INVESTIGATION RESULT CODE: TAASTRUP/MAINBOARD. CLOSURE RATIONALE: COMPLAINT VERIFIED, BEING TRACKED AS A TREND.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 (REF NATUS COMPLAINT #(B)(4)). DEVICE AND ALL COMPONENTS OF THE DEVICE WERE RECEIVED FOR EVALUATION (PART 8-35-24201 LOT / SERIAL (B)(6) ). REPAIR NOTES: MAINBOARD DEFECT(C415 BURNED) . CHARTR VNG/ ENG REPLACED WITH NEW ATO(SN:(B)(6) ). DEFECT LIGHTBAR REPLACED WITH NEW( W235520-015). DAMAGED POWER SUPPLY AND POWER CORD AUS ADDED FUNCTION AND FINAL TEST PERFORMED. COVER TOP AND BOTTOM, COVER PLATE (SN), COVER SIDE, FACE CUSHION AND IR FILTER (BIG AND SMALL) DAMAGED AND REPLACED WITH NEW. COAX SIGNAL CABLES CORRODED AND REPLACED WITH NEW. CAMERA AND LIGHT ADJUSTED, AND FINAL TEST PERFORMED. FINAL REVIEW AND APPROVAL OF INVESTIGATION DETAILS TO BE CARRIED OUT BEFORE CLOSURE OF THIS COMPLAINT.

    Description of Event or Problem · 0

    ICS CHARTR 200 (VNG) WHITE SMOKE COMING OUT OF MAIN CHARTR. CUSTOMER ADVISED THEY TRIED TO POWER ON THE CHARTR BUT IT WASN'T POWERING ON, THEY FIRST SMELT A BURNING SMELL THEN WHITE SMOKE APPEARED FROM THE CHARTR. THERE WERE NO PATIENTS WHEN THIS OCCURRED.

    Description of Event or Problem · 0

    ICS CHARTR 200 (VNG) WHITE SMOKE COMING OUT OF MAIN CHARTR. CUSTOMER ADVISED THEY TRIED TO POWER ON THE CHARTR BUT IT WASN'T POWERING ON, THEY FIRST SMELT A BURNING SMELL THEN WHITE SMOKE APPEARED FROM THE CHARTR. THERE WERE NO PATIENTS WHEN THIS OCCURRED.

    Description of Event or Problem · 0

    ICS CHARTR 200 (VNG) WHITE SMOKE COMING OUT OF MAIN CHARTR. CUSTOMER ADVISED THEY TRIED TO POWER ON THE CHARTR BUT IT WASN'T POWERING ON, THEY FIRST SMELT A BURNING SMELL THEN WHITE SMOKE APPEARED FROM THE CHARTR. THERE WERE NO PATIENTS WHEN THIS OCCURRED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT (REF NATUS COMPLAINT #(B)(4)) ICS CHARTR 200 (VNG) WHITE SMOKE COMING OUT OF MAIN CHARTR, CUSTOMER ADVISED THEY TRIED TO POWER ON THE CHARTR BUT IT WASN'T POWERING ON, THEY FIRST SMELT A BURNING SMELL THEN WHITE SMOKE APPEARED FROM THE CHARTR, THERE WERE NO PATIENTS WHEN THIS OCCURED. ALL COMPONENTS OF THE DEVICE WILL BE RETURNED FOR EVALUATION, REF PART 8-35-24201 LOT / SERIAL (B)(4). NO PATIENT INVOLVEMENT. NO INJURY OR DEATH.

    Description of Event or Problem · 1

    ICS CHARTR 200 (VNG) WHITE SMOKE COMING OUT OF MAIN CHARTR. CUSTOMER ADVISED THEY TRIED TO POWER ON THE CHARTR BUT IT WASN'T POWERING ON, THEY FIRST SMELT A BURNING SMELL THEN WHITE SMOKE APPEARED FROM THE CHARTR. THERE WERE NO PATIENTS WHEN THIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684100 1068 ICS CHARTR 200 VNG INCL. LIGHTBAR LB-200 AND VIDEO GOOGLE VG40 1068 ICS CHARTR 200 VNG INCL. LIGHTBAR LB-200 AND VIDEO GOOGLE VG40 GWN NATUS MEDICAL DENMARK APS 8-04-11910

    Patients

    Seq Age Sex Outcome Treatment
    1