BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 9182982 · Received October 11, 2019

    Report

    Report Number
    8030229-2019-00565
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 17, 2019
    Report Date
    December 18, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT ON 09/18/19, CUSTOMER AT (B)(6) HEALTH PARTNERS REPORTED THE FOLLOWING ISSUE: AT 1839 ALL SCREENS "COMM LOSS" FOR SECONDS THIS WAS PROVIDED TO NKA TECHNICAL SUPPORT (TS) FROM THE HOSPITAL'S DEPARTMENT LOGS. THE INCIDENT OCCURRED ON (B)(6) 2019. NO FURTHER INFORMATION WILL BE PROVIDED FROM THE HOSPITAL. SERVICE REQUESTED: NONE . SERVICE PERFORMED: NONE. MISSING INFORMATION/REQUIRED INFORMATION: THE DEVICE INFORMATION ASSOCIATED WITH THE COMPLAINT FILE IS NOT ENTERED IN THE "PRODUCT" FIELD. THIS IS A KNOWN ISSUE AND CAPA 18-033 HAS BEEN OPENED TO ADDRESS THIS. INVESTIGATION RESULT: THERE WAS A REPORTED INCIDENT IN WHICH ALL SCREENS WERE REPORTED TO DISPLAY "COMM LOSS" FOR SECONDS AT THE SAME TIME. FURTHER INVESTIGATION OF THE ISSUE IS LIMITED AS THE DEVICE AND/OR LOGS WERE NOT RETRIEVED FOR EVALUATION, NOR WAS THE DEVICE PRODUCT INFORMATION PROVIDED. THE DETAILS SURROUNDING THE INCIDENT WERE NOT PROVIDED AND INFORMATION ON THE EXTENT OF ANY TROUBLESHOOTING IS UNKNOWN. TRENDING OF TICKETS OPENED AT MERCY HEALTH PARTNERS FOUND 14 REPORTED INCIDENCES OF "COMM/COMMUNICATION LOSS" BETWEEN 11/07/18 TO PRESENT. ID DESCRIPTION CREATED ON PRODUCT ID: 43974: SPONTANEOUS RESTARTS AND COMM LOSS, 05/23/2018 10:20 AM MU-631RA. 59594: COMMUNICATION LOSS ON GZ TELEMETRY, 05/23/2019 02:01 AM PU-681RA. 61204: COMM LOSS ON ALL GZ'S AND COMM LOSS ON ALL RNS, 05/23/2019 06:13 PM PU-681RA . 63981: TILES ARE INTERMITTENTLY SHOWING COMM LOSS, 05/23/2019 09:51 PM A/RNS-9703-242. 58093: 5 RNS IN INTERMITTENT COMM LOSS, 05/23/2019 09:31 PM A/RNS-9703-242. 60045: COMM LOSS, 05/23/2019 03:54 AM PU-681RA 60488 COMM LOSS 05/23/2019 08:38 AM PU-681RA. 62543: COMM LOSS ON ALL THEIR CNS, TELE GZ 05/23/2019 11:16 PM PU-681RA 64272 COMMUNICATION LOSS ON ALL TELES ON .40 "D" SEGMENT 05/23/2019 03:42 PM PU-681RA. 5934:2 GZ DEVICES IN COMM LOSS, 05/23/2019 05:35 AM GZ-130PA 59443 COMM LOSS 05/23/2019 08:00 AM GZ-130PA. 59444: COMM LOSS, 05/23/2019 08:02 AM GZ-130PA. 65313: GZ TELE IN COMM LOSS, (B)(6) 2019 09:57 PM PU-681RA. 67704: INTERMITTANT COMM LOSS ON ALL CENTRAL STATIONS LEVEL 6, (B)(6) 2019 10:30 AM PU-681RA . NO FURTHER COMMUNICATION LOSS WAS REPORTED AFTER 09/06/19. THE CUSTOMER WAS NOT WILLING TO PROVIDE FURTHER INFORMATION. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO MAKE ANY DETERMINATION OF THE ROOT CAUSE. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO MAKE ANY DETERMINATION OF THE ROOT CAUSE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT AT 1839 HOURS ALL SCREENS DISPLAYED A "COMM LOSS" ERROR MESSAGE. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT AT 1839 HOURS ALL SCREENS DISPLAYED A "COMM LOSS" ERROR MESSAGE. THIS COMPLAINT WAS CREATED TO DOCUMENT INFORMATION NOTED ON DEPARTMENT LOGS FROM THE HOSPITAL. THE HOSPITAL WILL NOT BE PROVIDING ANY ADDITIONAL INFORMATION. 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. CENTRAL MONITOR STATION WAS ADDED AS LEAVING THIS FIELD BLANK WILL RESULT IN A FAILED SUBMISSION.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT AT 1839 HOURS ALL SCREENS DISPLAYED A "COMM LOSS" ERROR MESSAGE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975142 NI CENTRAL MONITOR STATION MHX NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1