BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 9501066 · Received December 20, 2019

    Report

    Report Number
    8030229-2019-00737
    Event Type
    Death
    Date Received
    December 20, 2019
    Date of Event
    November 23, 2019
    Report Date
    February 25, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRT
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2019, CUSTOMER AT (B)(6) REPORTED A PATIENT PASSED WHILE BEING MONITORED ON AN NK TELEMETRY DEVICE. INVESTIGATION CONCLUSION: IT IS NOT KNOWN WHETHER AN NK DEVICE MALFUNCTION OR DEFICIENCY MAY HAVE CONTRIBUTED TO THE PATIENT EVENT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT ALONG WITH INFORMATION OF THE DEVICE INVOLVED HOWEVER NO FURTHER INFORMATION HAVE BEEN PROVIDED. DUE TO THE LACK OF INFORMATION AVAILABLE, NO ROOT CAUSE ANALYSIS OR RISK ASSESSMENT COULD BE PERFORMED.

    Description of Event or Problem · 0

    THE DIRECTOR OF IS AND CLINICAL ENGINEERING REPORTED THAT A PATIENT EXPIRED WHILE BEING MONITORED ON AN NK TELEMETRY TRANSMITTER. THAT IS ALL THE INFORMATION THAT WAS RECEIVED FROM THEM AS THEY ARE STILL INVESTIGATING THIS ISSUE INTERNALLY. ATTEMPTS HAVE BEEN MADE TO GET ADDITIONAL DESCRIPTION OF EVENT AND PATIENT DETAILS WITH NO RESPONSE AS OF YET. IT IS UNCLEAR IF THE DEVICE MALFUNCTIONED AND NO DEVICE MODEL OR SERIAL NUMBER INFORMATION WAS PROVIDED. HOWEVER, AS THERE HAS BEEN A PATIENT DEATH REPORTED TO US, WE ARE REPORTING THIS COMPLAINT TO ERR ON THE SIDE OF CAUTION.

    Additional Manufacturer Narrative · 1

    THE DIRECTOR OF IS AND CLINICAL ENGINEERING REPORTED THAT A PATIENT EXPIRED WHILE BEING MONITORED ON AN NK TELEMETRY TRANSMITTER. THAT IS ALL THE INFORMATION THAT WAS RECEIVED FROM THEM AS THEY ARE STILL INVESTIGATING THIS ISSUE INTERNALLY. ATTEMPTS HAVE BEEN MADE TO GET ADDITIONAL DESCRIPTION OF EVENT AND PATIENT DETAILS WITH NO RESPONSE AS OF YET. IT IS UNCLEAR IF THE DEVICE MALFUNCTIONED AND NO DEVICE MODEL OR SERIAL NUMBER INFORMATION WAS PROVIDED. HOWEVER, AS THERE HAS BEEN A PATIENT DEATH REPORTED TO US, WE ARE REPORTING THIS COMPLAINT TO ERR ON THE SIDE OF CAUTION. 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. DATE OF PATIENT DEATH. MODEL NUMBER, CATALOG NUMBER, SERIAL NUMBER, UNIQUE IDENTIFIER (UDI) NUMBER APPROXIMATE AGE OF DEVICE. NO MODEL/SERIAL PROVIDED SO AGE OF DEVICE IS NOT KNOWN. PMA/510(K) NUMBER. NO MODEL PROVIDED SO 510K IS NOT KNOWN. DEVICE MANUFACTURER DATE. NO MODEL / SERIAL NUMBER WAS PROVIDED AND UNABLE TO DETERMINE DEVICE MANUFACTURER DATE.

    Description of Event or Problem · 1

    THE DIRECTOR OF IS AND CLINICAL ENGINEERING REPORTED THAT A PATIENT EXPIRED WHILE BEING MONITORED ON AN NK TELEMETRY TRANSMITTER. THAT IS ALL THE INFORMATION THAT WAS RECEIVED FROM THEM AS THEY ARE STILL INVESTIGATING THIS ISSUE INTERNALLY. ATTEMPTS HAVE BEEN MADE TO GET ADDITIONAL DESCRIPTION OF EVENT AND PATIENT DETAILS WITH NO RESPONSE AS OF YET. IT IS UNCLEAR IF THE DEVICE MALFUNCTIONED AND NO DEVICE MODEL OR SERIAL NUMBER INFORMATION WAS PROVIDED. HOWEVER, AS THERE HAS BEEN A PATIENT DEATH REPORTED TO US, WE ARE REPORTING THIS COMPLAINT TO ERR ON THE SIDE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300751 NI TRANSMITTER DRT NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death