BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 14607699 · Received June 6, 2022

    Report

    Report Number
    8030229-2022-02882
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 9, 2022
    Report Date
    August 17, 2022
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED BEING UNABLE TO SEE THE PATIENT'S VITALS ON THE CENTRAL NURSE'S STATION (CNS). ACCORDING TO THE CUSTOMER, THE SECTOR FOR THAT ROOM IS COMPLETELY BLANK. TECHNICAL SUPPORT (TS) IS WORKING WITH THE CUSTOMER TO RESOLVE THE REPORTED ISSUE. THERE WAS NO PATIENT INJURY REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED BEING UNABLE TO SEE THE PATIENT'S VITALS ON THE CENTRAL NURSE'S STATION (CNS). ACCORDING TO THE CUSTOMER, THE SECTOR FOR THAT ROOM IS COMPLETELY BLANK. TECHNICAL SUPPORT (TS) IS WORKING WITH THE CUSTOMER TO RESOLVE THE REPORTED ISSUE. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATON SUMMARY: DURING FOLLOW-UP WITH THE CUSTOMER, IT WAS IDENTIFIED THAT THE INCORRECT ID NUMBER WAS ENTERED BY STAFF. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE OF THE ISSUE IS USER ERROR. THERE WAS NO MALFUNCTION OF AN NK DEVICE. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THIS REPORT: B2 D4 LOT # & EXPIRATION DATE D6A & D6B D7B F1 - F14 G4 DEVICE BLA NUMBER G5 G7 H2 H7 H9 THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6 ATTEMPT # 1: (B)(6) 2022 A PHONE CALL WAS MADE IN AN ATTEMPT TO GATHER PATIENT AND DEVICE INFORMATION, A VOICE MAIL WAS LEFT FOR KIM TO CALL ME BACK WITH THE PATIENT AND DEVICE INFORMATION AS WELL AS AN EMAIL. ATTEMPT # 2: 05/19/2022 A PHONE CALL WAS MADE IN AN ATTEMPT TO GATHER PATIENT AND DEVICE INFORMATION, A VOICE MAIL WAS LEFT FOR KIM TO CALL ME BACK WITH THE PATIENT AND DEVICE INFORMATION AS WELL AS AN EMAIL. ATTEMPT # 3 05/26/2022 A PHONE CALL WAS MADE IN AN ATTEMPT TO GATHER PATIENT AND DEVICE INFORMATION, A VOICE MAIL WAS LEFT FOR KIM TO CALL ME BACK WITH THE PATIENT AND DEVICE INFORMATION AS WELL AS AN EMAIL. (B)(6) 2022 A PHONE CALL WAS MADE IN AN ATTEMPT TO GATHER PATIENT AND DEVICE INFORMATION, A VOICE MAIL WAS LEFT FOR KIM TO CALL ME BACK WITH THE PATIENT AND DEVICE INFORMATION AS WELL AS AN EMAIL. ATTEMPT # 2:(B)(6) 2022 A PHONE CALL WAS MADE IN AN ATTEMPT TO GATHER PATIENT AND DEVICE INFORMATION, A VOICE MAIL WAS LEFT FOR KIM TO CALL ME BACK WITH THE PATIENT AND DEVICE INFORMATION AS WELL AS AN EMAIL. ATTEMPT # 3 (B)(6) 2022 A PHONE CALL WAS MADE IN AN ATTEMPT TO GATHER PATIENT AND DEVICE INFORMATION, A VOICE MAIL WAS LEFT FOR KIM TO CALL ME BACK WITH THE PATIENT AND DEVICE INFORMATION AS WELL AS AN EMAIL. B7 05/12/2022 A PHONE CALL WAS MADE IN AN ATTEMPT TO GATHER PATIENT AND DEVICE INFORMATION, A VOICE MAIL WAS LEFT FOR KIM TO CALL ME BACK WITH THE PATIENT AND DEVICE INFORMATION AS WELL AS AN EMAIL. ATTEMPT # 2: (B)(6) 2022 A PHONE CALL WAS MADE IN AN ATTEMPT TO GATHER PATIENT AND DEVICE INFORMATION, A VOICE MAIL WAS LEFT FOR KIM TO CALL ME BACK WITH THE PATIENT AND DEVICE INFORMATION AS WELL AS AN EMAIL. ATTEMPT # 3 (B)(6) 2022 A PHONE CALL WAS MADE IN AN ATTEMPT TO GATHER PATIENT AND DEVICE INFORMATION, A VOICE MAIL WAS LEFT FOR KIM TO CALL ME BACK WITH THE PATIENT AND DEVICE INFORMATION AS WELL AS AN EMAIL. D10 (B)(6) 2022 A PHONE CALL WAS MADE IN AN ATTEMPT TO GATHER PATIENT AND DEVICE INFORMATION, A VOICE MAIL WAS LEFT FOR KIM TO CALL ME BACK WITH THE PATIENT AND DEVICE INFORMATION AS WELL AS AN EMAIL. ATTEMPT # 2: (B)(6) 2022 A PHONE CALL WAS MADE IN AN ATTEMPT TO GATHER PATIENT AND DEVICE INFORMATION, A VOICE MAIL WAS LEFT FOR KIM TO CALL ME BACK WITH THE PATIENT AND DEVICE INFORMATION AS WELL AS AN EMAIL. ATTEMPT # 3 (B)(6) 2022 A PHONE CALL WAS MADE IN AN ATTEMPT TO GATHER PATIENT AND DEVICE INFORMATION, A VOICE MAIL WAS LEFT FOR KIM TO CALL ME BACK WITH THE PATIENT AND DEVICE INFORMATION AS WELL AS AN EMAIL. THE FOLLOWING FIELDS ARE NOT AVAILABLE (N/A) TO THIS REPORT: E1 - EMAIL ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW UP, WHAT TYPE? H10 ADDITIONAL MANUFACTURER NARRATIVE MANUFACTURER REFERENCES # (B)(4) FOLLOW UP 001.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED BEING UNABLE TO SEE THE PATIENT'S VITALS ON THE CENTRAL NURSE'S STATION (CNS). THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED BEING UNABLE TO SEE THE PATIENT'S VITALS ON THE CENTRAL NURSE'S STATION (CNS). THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542091 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown