BEUDAMED
    FDA Adverse Event Death Summary report: N

    CNS-6201A

    MDR report key: 11849553 · Received May 19, 2021

    Report

    Report Number
    8030229-2021-00289
    Event Type
    Death
    Date Received
    May 19, 2021
    Date of Event
    April 19, 2021
    Report Date
    April 19, 2022
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT DETAILS: ON (B)(6) 2021, CUSTOMER REPORTED A PATIENT DECEASED WHILE BEING MONITORED ON A TELEMETRY DEVICE (ZM-540PA S/N: (B)(6). THE EVENT OCCURRED ON 4/18/2021. THE ZM TELEMETER WAS BEING MONITORED AT THE CENTRAL STATION (CNS). CUSTOMER COLLECTED THE LOGS AND REQUEST FOR LOG ANALYSIS TO UNDERSTAND THE EVENT AND WHETHER DEVICE ALARMED AS INTENDED. INVESTIGATION SUMMARY: LOG ANALYSIS RESULTS INDICATE THAT THERE WAS A CRISIS ALARM AT ABOUT THE SAME TIME IN TWO BEDS, 6WNTX-15 AND 9198. ON (B)(6) 2021 14:48:44 ASYSTOLE BED - 9198 PRIORITY - CRISIS MSG - ASYSTOLE ON (B)(6) 2021 14:47:41 V. FIB BED - 9198 PRIORITY - CRISIS MSG - V. FIB ON (B)(6) 2021 14:45:58 V. FIB BED - 9198 PRIORITY - CRISIS MSG - V. FIB ON (B)(6) 2021 14:40:46 ASYSTOLE BED - 9198 PRIORITY - CRISIS MSG - ASYSTOLE ON (B)(6) 2021 14:29:01 ASYSTOLE BED - 9198 PRIORITY - CRISIS MSG - ASYSTOLE ON (B)(6) 2021 14:28:44 V. FIB BED - 9198 PRIORITY - CRISIS MSG - V. FIB ON (B)(6) 2021 14:28:06 ASYSTOLE BED - 9198 PRIORITY - CRISIS MSG - ASYSTOLE ON (B)(6) 2021 14:25:32 ASYSTOLE BED - 9198 PRIORITY - CRISIS MSG - ASYSTOLE ON (B)(6) 2021 14:25:29 MESSAGE SHOWN BED - 6WNTX-15 PRIORITY - CRISIS MSG - ASYSTOLE ON (B)(6) 2021 14:25:29 ASYSTOLE BED - 6WNTX-15 PRIORITY - CRISIS MSG - ASYSTOLE ON (B)(6) 2021 14:23:00 MESSAGE SHOWN BED - 6WNTX-15 PRIORITY - CRISIS MSG - ASYSTOLE ON (B)(6) 2021 14:23:00 ASYSTOLE BED - 6WNTX-15 PRIORITY - CRISIS MSG - ASYSTOLE THIS INFORMATION WAS PROVIDED TO CUSTOMER. THERE WAS NO INDICATION THAT NIHON KOHDEN DEVICES CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS: TRANSMITTER: MODEL#: ZM-540PA. SERIAL#: (B)(6). DEVICE MANUFACTURER DATA: 02/05/2015. UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR PATIENT HAS DIED UNDER UNCLEAR CIRCUMSTANCES. AT THIS POINT THERE IS NO DEFINITIVE ANSWER IF THIS DEATH WAS ANTICIPATED OR WAS IT CONTRIBUTED BY DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEIR PATIENT HAS DIED UNDER UNCLEAR CIRCUMSTANCES. AT THIS POINT THERE IS NO DEFINITIVE ANSWER IF THIS DEATH WAS ANTICIPATED OR WAS IT CONTRIBUTED BY DEVICE MALFUNCTION. 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. ATTEMPT #1: 05/07/2021 EMAILED CUSTOMER VIA (B)(6) FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2: 05/14/2021 EMAILED CUSTOMER VIA (B)(6) FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3: 05/18/2021 EMAILED CUSTOMER VIA (B)(6) FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS: TRANSMITTER: MODEL #: ZM-540PA, SERIAL #: (B)(4), DEVICE MANUFACTURER DATA: 02/05/2015, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR PATIENT HAS DIED UNDER UNCLEAR CIRCUMSTANCES. AT THIS POINT THERE IS NO DEFINITIVE ANSWER IF THIS DEATH WAS ANTICIPATED OR WAS IT CONTRIBUTED BY DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744297 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death TRANSMITTER.| TRANSMITTER.| TRANSMITTER