BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSM-1901

    MDR report key: 16969519 · Received May 19, 2023

    Report

    Report Number
    8030229-2023-03522
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 22, 2023
    Report Date
    July 14, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921112168
    PMA / PMN Number
    K151080
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THIS G9 IS DISCHARGING PATIENTS ON ITS OWN. ACCORDING TO THE CUSTOMER, THE UNIT WILL DISCHARGE AND THEN THEY'RE HAVING TO READMIT THE PATIENT. PER THE CUSTOMER, THIS HAPPENED MULTIPLE TIMES WITH THIS UNIT. THE CUSTOMER REQUESTED FOR NK TO LOOK AT THE LOGS FROM THE G9 AND THE CENTRAL NURSE'S STATION (CNS). THE CUSTOMER WILL SEND IN THE UNIT TO BE REPAIRED. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: REVIEW OF THE LOGS CONFIRMED THAT THE CNS OPERATION AT IP ADDRESS 10.103.39.226 HAD DISCHARGED G9. SINCE THE CNS WITH IP ADDRESS 10.103.39.44 IS ALSO PRESENT, IT IS POSSIBLE THAT THE "DISCHARGE" OPERATION WAS PERFORMED FROM ANOTHER CNS (10.103.39.226), WHICH MAY HAVE BEEN RECOGNIZED AS "DISCHARGE" PERFORMED ON ITS OWN. MANUFACTURER REFERENCES # (B)(4) - 171351 FOLLOW UP 001.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THIS G9 IS DISCHARGING PATIENTS ON ITS OWN. ACCORDING TO THE CUSTOMER, THE UNIT WILL DISCHARGE AND THEN THEY'RE HAVING TO READMIT THE PATIENT. PER THE CUSTOMER, THIS HAPPENED MULTIPLE TIMES WITH THIS UNIT. THE CUSTOMER REQUESTED FOR NK TO LOOK AT THE LOGS FROM THE G9 AND THE CENTRAL NURSE'S STATION (CNS). THE CUSTOMER WILL SEND IN THE UNIT TO BE REPAIRED. 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: 05/01/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 05/08/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 05/12/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; I AM UNABLE TO PROVIDE ANY PATIENT INFORMATION. ATTEMPT # 1: 05/01/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 05/08/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 05/12/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; I AM UNABLE TO PROVIDE ANY PATIENT INFORMATION. B7 ATTEMPT # 1: 05/01/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 05/08/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 05/12/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; I AM UNABLE TO PROVIDE ANY PATIENT INFORMATION. D10 ATTEMPT # 1: 05/01/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR DEVICE INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 05/08/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR DEVICE INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 05/12/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR DEVICE INFORMATION: THE CUSTOMER REPLIED BY STATING; I AM UNABLE TO PROVIDE ANY PATIENT INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THIS G9 IS DISCHARGING PATIENTS ON ITS OWN. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THIS G9 IS DISCHARGING PATIENTS ON ITS OWN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852946 CSM-1901 VITAL SIGNS MONITOR MHX NIHON KOHDEN CORPORATION CSM-1901 NA 04931921112168

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CNS| CNS