BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARAVUE

    MDR report key: 13534122 · Received February 15, 2022

    Report

    Report Number
    3004762958-2022-00001
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    July 21, 2021
    Report Date
    February 14, 2022
    Manufacturer
    NISSHA MEDICAL TECHNOLOGIES SAS
    Product Code
    DRX
    PMA / PMN Number
    K101685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FULL PRODUCT LIST FOR US: 32028776 50401-US IP-SET N3 - PEDIATRIC-US; 32028777 50600-US IP SET M3 RT ADULT-US; 32028778 50601-US IP SET M5 RT ADULT-US; 32028779 50602-US IP SET 12 RT ADULT-US; 32028780 50603-US IP SET 6V RT ADULT-US; 32028781 50604-US IP SET 5V RT ADULT-US. 7/21/2021 INTERNAL TESTING WAS PERFORMED FOLLOWING AN INDICATION FROM A THIRD-PARTY POTENTIAL CUSTOMER RELATED TO THEIR OWN PRODUCT DEVELOPMENT.

    Description of Event or Problem · 0

    NISSHA MEDICAL TECHNOLOGIES SAS REGISTRATION NUMBER: (B)(4). A FOREIGN MANUFACTURER LOCATED IN FRANCE ("NISSHA MEDICAL SAS") IDENTIFIED A FAILURE OF THE CLARAVUE PATIENT MONITORING DEVICE FAMILY THAT TRANSMITS PATIENT MONITORING SIGNALS TO THIRD-PARTY DEVICES ("IP SET") TO PERFORM TO AN ESTABLISHED SPECIFICATION. TESTING PERFORMED INTERNALLY AND BY A THIRD-PARTY POTENTIAL CUSTOMER RELATED TO PRODUCT DEVELOPMENT IDENTIFIED THAT ONE PORTION OF THE IP SET PRODUCT DID NOT PERFORM IN COMPLIANCE WITH SPECIFICATIONS OUTLINED IN ANSI/AAMI EC53:2013/ (R)2020 ECG TRUNK CABLES AND PATIENT LEADWIRES. SPECIFICALLY, THE PRODUCT DID NOT MEET SECTION 5.3.9 *DIELECTRIC WITHSTAND VOLTAGE, WHICH REQUIRES THE ASSEMBLY TO WITHSTAND, WITHOUT BREAKDOWN, AN APPLICATION OF 5,000 V D.C. THE PRODUCT LABELING (INSTRUCTIONS FOR USE) INDICATES COMPLIANCE WITH THE EC53 STANDARD. COMPLIANCE WITH THE STANDARD IS NOT REQUIRED IF THE PRODUCT IS LABELED "NOT DEFIBRILLATION PROOF" IN ACCORDANCE WITH THE LABELING REQUIREMENTS PROVIDED IN SECTION 5.1.5 OF THE STANDARD; HOWEVER, THE PRODUCTS DO NOT CONTAIN SUCH LABELING. THERE HAVE BEEN NO REPORTS OF ADVERSE EVENTS OR INJURIES RELATED TO THE MALFUNCTION. ADDITIONALLY, THERE HAVE BEEN NO REPORTS OF THE MALFUNCTION BY ANY END USERS IN THE FIELD. ATTACHED IS A TECHNICAL ANALYSIS OF THE MALFUNCTION PREPARED BY GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/VERMED/BIOMEDICAL INNOVATIONS. NOTE: THIS REPORT BEING COMPILED AND SUBMITTED BY: GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/VERMED/BIOMEDICAL INNOVATIONS, THE U.S. AGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157349 CLARAVUE PRE- WIRED ELECTRODE DRX NISSHA MEDICAL TECHNOLOGIES SAS 50401-US;50600-US;50601- US;50602-US;50603-US;50604- US ALL LOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown