BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 17330078 · Received July 14, 2023

    Report

    Report Number
    8030229-2023-03650
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    June 16, 2023
    Report Date
    August 7, 2024
    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
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THIS CENTRAL NURSES STATION (CNS) SPONTANEOUSLY SHUT DOWN, AND THE SYSTEM WOULD NOT BOOT-UP PAST THE BIOS SCREEN. NO PATIENT HARM WAS REPORTED. THE BME RESOLVED THE ISSUE BY DISCONNECTING THE CONNECTOR FOR THE ALARM LIGHTS BEFORE BOOTING UP THE CNS. ONCE THE CNS WAS UP AND RUNNING, THE BME RECONNECTED THE ALARM LIGHTS, AND THE SYSTEM FUNCTIONED AS EXPECTED. INVESTIGATION SUMMARY: THE CUSTOMER LATER REPORTED ON (B)(6) 2023 THAT THEY WERE NOT PLANNING TO SEND IN THE UNIT FOR REPAIR AS THEY WERE ABLE TO BOOT UP THE DEVICE AFTER UNPLUGGING THE CONNECTOR FOR THE ALARM LIGHTS. HOWEVER, THE ISSUE RECURRED ON (B)(6) 2023, AND A REPAIR/LOANER PROCESS WAS INITIATED UNDER TICKET (B)(4). UNDER TICKET (B)(4), THE CUSTOMER REPORTED THAT THE CNS STOPPED WORKING, AND WHEN TRYING TO REBOOT THE UNIT, IT WOULD NOT BOOT PAST BIOS OR WINDOWS; IT WOULD JUST DISPLAY A B4 ERROR. MULTIPLE FOLLOW-UP REQUESTS WERE SENT TO THE CUSTOMER REGARDING THE RETURN OF THE DEVICE ON (B)(6) 2023, BUT THEY WERE UNRESPONSIVE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE WE HAVE NOT RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. POSSIBLE CAUSE OF THE SPONTANEOUS SHUTDOWN AND STARTUP FAILURE IS LIKELY RELATED TO HARDWARE COMPONENT FAILURE. HARDWARE COMPONENT FAILURE CAN OCCUR THROUGH PHYSICAL DAMAGE OR FLUID INTRUSION FROM USER MISHANDLING, POWER ISSUES FROM OUTAGES OR SURGES, WHICH CAN AFFECT THE INTEGRITY OF ELECTRONIC COMPONENTS, OR WEAR-AND-TEAR, WHICH DEPENDS ON DEVICE AGE AND FREQUENCY OF USE. A REVIEW OF THE COMPLAINT DEVICE'S SERIAL NUMBER SHOWS THAT THE DEVICE IS 2 YEARS OLD. A REVIEW OF THE CUSTOMER'S COMPLAINT HISTORY FROM THE PAST 2 YEARS FOR CNS DEVICES SHOWS 6 SIMILAR COMPLAINTS UNDER TICKETS 98428, 103151, 144876, 151130, 151710, AND 163983. FOR TICKETS 98428, 144876, 151130, 151710, AND 163983, THE ISSUES WERE FOUND TO BE DUE TO HARD DRIVE CORRUPTION/FAILURE AND RESOLVED THROUGH HDD RE-IMAGING AND REPLACEMENT. A CAUSE WAS NOT DETERMINED FOR TICKET 103151, AS THE CUSTOMER WAS UNRESPONSIVE. THE CNS OPERATOR'S MANUAL RECOMMENDS PERIODIC REPLACEMENT OF THE HDD EVERY 2 YEARS. POSSIBLE HARDWARE COMPONENT FAILURE, SUCH AS HDD CORRUPTION/FAILURE, MAY BE RELATED TO A LACK OF MAINTENANCE. NK WILL CONTINUE TO MONITOR AND TREND SIMILAR COMPLAINTS. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NONE WERE PROVIDED. A2 - A6. B6 - B7. D10 . ATTEMPT #1 06/19/2023 EMAILED THE BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION: NO REPLY WAS RECEIVED. ATTEMPT #2 06/23/2023 EMAILED THE BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION: NO REPLY WAS RECEIVED. ATTEMPT #3 06/27/2023 EMAILED THE BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION: RECEIVED A RESPONSE FROM THE BME STATING THEY WERE NOT PLANNING ON SENDING THE CNS IN FOR REPAIR, AS IT WAS ABLE TO BOOT UP. BME REPLIED, "UNKNOWN" TO ALL PATIENT INFORMATION AND CONCOMITANT MEDICAL DEVICES. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: BSM(S) MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA. TRANSMITTER(S) MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES. H10 ADDITIONAL MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THIS CENTRAL NURSES STATION (CNS) SPONTANEOUSLY SHUT DOWN, AND THE SYSTEM WOULD NOT BOOT-UP PAST THE BIOS SCREEN. NO PATIENT HARM WAS REPORTED. THE BME RESOLVED THE ISSUE BY DISCONNECTING THE CONNECTOR FOR THE ALARM LIGHTS BEFORE BOOTING UP THE CNS. ONCE THE CNS WAS UP AND RUNNING, THE BME RECONNECTED THE ALARM LIGHTS, AND THE SYSTEM FUNCTIONED AS EXPECTED. 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. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NONE WERE PROVIDED. ATTEMPT #1 06/19/2023 EMAILED THE BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION AND THE CONCOMITANT MEDICAL DEVICE: NO REPLY WAS RECEIVED. ATTEMPT #2 06/23/2023 EMAILED THE BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION AND THE CONCOMITANT MEDICAL DEVICE: NO REPLY WAS RECEIVED. ATTEMPT #3 06/27/2023 EMAILED THE BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION AND THE CONCOMITANT MEDICAL DEVICE: RECEIVED A RESPONSE FROM THE BME STATING THEY WERE NOT PLANNING ON SENDING THE CNS IN FOR REPAIR, AS IT WAS ABLE TO BOOT UP. BME REPLIED, "UNKNOWN" TO ALL PATIENT INFORMATION AND CONCOMITANT MEDICAL DEVICES. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES**. CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM CNS-6801A TO PU-681RA. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM CNS-6801A TO PU-681RA. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PRODUCTION IDENTIFIER (PI) INFORMATION. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A. ADDITIONAL INFORMATION: B4 DATA OF THIS REPORT. G6 TYPE OF REPORT. H2 IF FOLLOW UP, WHAT TYPE?

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THIS CENTRAL NURSES STATION (CNS) SPONTANEOUSLY SHUT DOWN, AND THE SYSTEM WOULD NOT BOOT-UP PAST THE BIOS SCREEN. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THIS CENTRAL NURSES STATION (CNS) SPONTANEOUSLY SHUT DOWN, AND THE SYSTEM WOULD NOT BOOT-UP PAST THE BIOS SCREEN. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THIS CENTRAL NURSES STATION (CNS) SPONTANEOUSLY SHUT DOWN, AND THE SYSTEM WOULD NOT BOOT-UP PAST THE BIOS SCREEN. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179901 PU-681RA CENTRAL MONITOR SYSTEM (CNS-6801A) MHX NIHON KOHDEN CORPORATION PU-681RA NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BSM(S)| BSM(S)| BSM(S)| TRANSMITTER(S)| TRANSMITTER(S)| TRANSMITTER(S)