BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 17818141 · Received September 26, 2023

    Report

    Report Number
    8030229-2023-03791
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    September 5, 2023
    Report Date
    July 26, 2024
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME 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. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM CNS-6801A TO PU-681RA. 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, PER THE FDA REQUEST.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED ANOTHER INSTANCE OF HEART RATE (HR) VALUES FROM 3 TELES NOT BEING DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS). THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: THE ROOT CAUSE FOR THE REPORTED ISSUE WAS FOUND TO BE A SOFTWARE DEFICIENCY FOR THE G5/G7 MONITOR VIEWING THE ZM TRANSMITTER IN HI-Q VIEW. COUNTERMEASURES WERE ADDED TO G5/G7 SOFTWARE VERSION 02-27 TO ADDRESS THE ISSUE. THE SOFTWARE WAS RELEASED 09/07/2023. THE ISSUE WAS RESOLVED AFTER THE G5/G7 SOFTWARE UPDATE TO VERSION 02-27. MANUFACTURER REFERENCES # (B)(4) FOLLOW UP 001.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED ANOTHER INSTANCE OF HEART RATE (HR) VALUES FROM 3 TELES NOT BEING DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS). 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. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6: ATTEMPT # 1: (B)(6) 2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3: (B)(6) 2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; KAISER PERMANENT (KP) WILL NOT BE PROVIDING ANY REQUESTED PHI/PII. B6: ATTEMPT # 1: (B)(6) 2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3: (B)(6) 2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; KAISER PERMANENT (KP) WILL NOT BE PROVIDING ANY REQUESTED PHI/PII. B7: ATTEMPT # 1: (B)(6) 2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3: (B)(6) 2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; KAISER PERMANENT (KP) WILL NOT BE PROVIDING ANY REQUESTED PHI/PII. D10: ATTEMPT # 1: (B)(6) 2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR DEVICE INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR DEVICE INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3: (B)(6) 2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR DEVICE INFORMATION: THE CUSTOMER REPLIED BY STATING; KAISER PERMANENT (KP) WILL NOT BE PROVIDING ANY REQUESTED PHI/PII.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ANOTHER INSTANCE OF HEART RATE (HR) VALUES FROM 3 TELES NOT BEING DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS). THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ANOTHER INSTANCE OF HEART RATE (HR) VALUES FROM 3 TELES NOT BEING DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS). THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ANOTHER INSTANCE OF HEART RATE (HR) VALUES FROM 3 TELES NOT BEING DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS). THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831166 PU-681RA CENTRAL MONITOR SYSTEM (CNS-6801A) MHX NIHON KOHDEN CORPORATION PU-681RA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown