BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-621R

    MDR report key: 20758477 · Received November 22, 2024

    Report

    Report Number
    8030229-2024-04564
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    November 5, 2024
    Report Date
    February 7, 2025
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS DISPLAYING HDD 1 FAILURE, AND THE SYSTEM WENT DOWN. THEY REMOVED HDD 2 AND PLACED IT INTO THE HDD 1 SLOT. THEN THEY BOOTED UP THE CNS. ONCE THE SOFTWARE WAS RUNNING, THEY INSERTED A NEW HDD INTO SLOT 2. THEY WERE NOW GETTING THE SAME MESSAGE AS BEFORE. TECH SUPPORT (TS) WALKED HIM THROUGH LOGGING OUT INTO WINDOWS TO START THE HDD REBUILD THROUGH THE INTEL STORAGE MATRIX MANAGER. ONCE THEY WERE ABLE TO GET THE HDD REBUILD STARTED, TS TOLD THEM THAT THIS WOULD TAKE AT LEAST 40 MINUTES TO AN HOUR AND DURING THAT TIME THEY COULD STILL HAVE THE CNS UP AND RUNNING. THE CUSTOMER STATED HE WILL CHECK ON THE CNS LATER IN THE DAY TO ENSURE THAT THE REBUILD WAS COMPLETED. NO PATIENT HARM WAS 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. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. D10 CONCOMITANT MEDICAL DEVICE ATTEMPT #1 (B)(6)2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 (B)(6)2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE THE ADDITIONAL DEVICE INFORMATION AS REQUESTED.

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS DISPLAYING HDD 1 FAILURE, AND THE SYSTEM WENT DOWN. THEY REMOVED HDD 2 AND PLACED IT INTO THE HDD 1 SLOT. THEN THEY BOOTED UP THE CNS. ONCE THE SOFTWARE WAS RUNNING, THEY INSERTED A NEW HDD INTO SLOT 2. THEY WERE NOW GETTING THE SAME MESSAGE AS BEFORE. TECH SUPPORT (TS) WALKED HIM THROUGH LOGGING OUT INTO WINDOWS TO START THE HDD REBUILD THROUGH THE INTEL STORAGE MATRIX MANAGER. ONCE THEY WERE ABLE TO GET THE HDD REBUILD STARTED, TS TOLD THEM THAT THIS WOULD TAKE AT LEAST 40 MINUTES TO AN HOUR AND DURING THAT TIME THEY COULD STILL HAVE THE CNS UP AND RUNNING. THE CUSTOMER STATED HE WILL CHECK ON THE CNS LATER IN THE DAY TO ENSURE THAT THE REBUILD WAS COMPLETED. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: THE HDDS ARE MECHANICAL COMPONENTS THAT MAY DETERIORATE THROUGH TIME AND MAY WEAR FROM CONTINUAL USE. POSSIBLE CAUSES OF FAILURE INCLUDE MECHANICAL FAILURE FROM IMPROPER USE/HANDLING, CORRUPTION OF THE FILES FROM ABNORMAL SHUTDOWNS OR VIRUSES, OR POWER ISSUES. OTHER POSSIBLE CAUSES OF THE ISSUE ARE POWER SURGES/INTERRUPTIONS AND WEAR AND TEAR. ANY EVENTS THAT INVOLVE FLUCTUATIONS AND CHANGES IN THE VOLTAGE SUCH AS POWER OUTAGES, POWER SURGES AND GENERATOR TESTS MAY DAMAGE THE HDDS. FLUID INTRUSION, DUST ACCUMULATION, OR A LACK OF MAINTENANCE ON FANS, AIR INTAKES, AND OTHER COMPONENTS MAY LEAD TO OVERHEATING OF THE HARD DRIVE AND SUBSEQUENT FAILURE. WHEN HARD DRIVES FAIL, THIS FAILURE CAN MANIFEST IN DIFFERENT WAYS. THERE CAN BE AN ERROR MESSAGE (E.G., "HDD ACCESS ERROR," "SSD ACCESS ERROR," "SSDX ERROR," "THRESHOLD BREACH"), OR THE DEVICE MAY REBOOT, THE DEVICE COULD DISPLAY A BLUE FAILURE SCREEN, OR THE DEVICE SCREEN COULD "FREEZE." THE UNIT MAY SOMETIME THEN RESTART, OR THE DEVICE MAY NEED TO HAVE THE HARD DRIVE REPLACED. SOMETIMES THE UNIT CAN BE REBUILT BY THE BACKUP DISK (I.E., THE SYSTEM HAS RAID (REDUNDANT ARRAY OF INDEPENDENT DISKS - WHICH PUTS MULTIPLE HARD DRIVES TOGETHER TO IMPROVE PERFORMANCE)). THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. D10 CONCOMITANT MEDICAL DEVICE ATTEMPT #1 11/08/2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 11/21/2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE THE ADDITIONAL DEVICE INFORMATION AS REQUESTED. 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. H11 ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS DISPLAYING HDD 1 FAILURE, AND THE SYSTEM WENT DOWN. THEY REMOVED HDD 2 AND PLACED IT INTO THE HDD 1 SLOT. THEN THEY BOOTED UP THE CNS. ONCE THE SOFTWARE WAS RUNNING, THEY INSERTED A NEW HDD INTO SLOT 2. THEY WERE NOW GETTING THE SAME MESSAGE AS BEFORE. TECH SUPPORT (TS) WALKED HIM THROUGH LOGGING OUT INTO WINDOWS TO START THE HDD REBUILD THROUGH THE INTEL STORAGE MATRIX MANAGER. ONCE THEY WERE ABLE TO GET THE HDD REBUILD STARTED, TS TOLD THEM THAT THIS WOULD TAKE AT LEAST 40 MINUTES TO AN HOUR AND DURING THAT TIME THEY COULD STILL HAVE THE CNS UP AND RUNNING. THE CUSTOMER STATED HE WILL CHECK ON THE CNS LATER IN THE DAY TO ENSURE THAT THE REBUILD WAS COMPLETED. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS DISPLAYING HDD 1 FAILURE, AND THE SYSTEM WENT DOWN. THEY REMOVED HDD 2 AND PLACED IT INTO THE HDD 1 SLOT. THEN THEY BOOTED UP THE CNS. ONCE THE SOFTWARE WAS RUNNING, THEY INSERTED A NEW HDD INTO SLOT 2. THEY WERE NOW GETTING THE SAME MESSAGE AS BEFORE. TECH SUPPORT (TS) WALKED HIM THROUGH LOGGING OUT INTO WINDOWS TO START THE HDD REBUILD THROUGH THE INTEL STORAGE MATRIX MANAGER. ONCE THEY WERE ABLE TO GET THE HDD REBUILD STARTED, TS TOLD THEM THAT THIS WOULD TAKE AT LEAST 40 MINUTES TO AN HOUR AND DURING THAT TIME THEY COULD STILL HAVE THE CNS UP AND RUNNING. THE CUSTOMER STATED HE WILL CHECK ON THE CNS LATER IN THE DAY TO ENSURE THAT THE REBUILD WAS COMPLETED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2600088 PU-621R CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION PU-621R NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NI.| NI.