BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 9131651 · Received September 27, 2019

    Report

    Report Number
    8030229-2019-00498
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    September 6, 2019
    Report Date
    December 10, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: ON (B)(6) 2019, CUSTOMER AT (B)(6) MEDICAL CENTER, INC REPORTED THE CNS-6201A (PU-621RA SN: (B)(6) ) DID NOT ALARM WHEN A PATIENT "WENT IN VTAC". PATIENT WAS MONITORED VIA TELEMETRY TRANSMITTER ZM-531PA. SERVICE REQUESTED: TROUBLESHOOTING/ASSISTANCE. SERVICE PERFORMED: CUSTOMER WAS PROVIDED EVENT INVESTIGATION GUIDE. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER, HOWEVER NO RESPONSE WAS RECEIVED. INVESTIGATION RESULT: THE CNS WARRANTY BEGAN 12/31/11. REVIEW OF DEVICE SAP HISTORY FOUND NO PREVIOUSLY REPORTED ISSUES RELATING TO ALARM FUNCTIONALITY. REVIEW OF TICKETS OPENED AT (B)(6) MEDICAL CENTER, INC FOUND ADDITIONAL ISSUES REPORTED RELATING TO ALARM. (1) (B)(6) REPORTED (B)(6) 2019: CUSTOMER REPORTED THE UNIT DID NOT ALARM FOR V-TACHYCARDIA. CUSTOMER WAS UNABLE TO PROVIDE EVENT LOGS HOWEVER ANALYSIS OF ALARM HISTORY AND ECG STRIPS FOUND CLEARLY IDENTIFIED PACING MARKS ON THE ECG STRIP AND BOTH PACING AND RATE ALARMS WERE LISTED IN THE ALARM HISTORY. (2) (B)(6) REPORTED (B)(6) 2018: CUSTOMER REPORTED ALARM WAS NOT TRIGGERED. IT WAS DISCOVERED THE DEVICE WAS SET TO NEONATE MODE AND ALARMS WERE TURNED OFF. DUE TO THE LACK OF INFORMATION AVAILABLE, INVESTIGATION IS LIMITED AND THE ROOT CAUSE COULD NOT BE DETERMINED. TRENDING OF ALARM RELATED ISSUES AT CUSTOMER FACILITY FOUND PREVIOUSLY REPORTED ISSUES WHICH WERE CAUSED DUE TO USER ERROR OR MISUNDERSTANDING OF DEVICE AND ALARM FUNCTIONALITY. THERE IS NO TREND OF ALARM ISSUES FOR PU-621RA SN: 73. INVESTIGATION CONCLUSION: DUE TO THE LACK OF INFORMATION AVAILABLE, INVESTIGATION IS LIMITED AND THE ROOT CAUSE COULD NOT BE DETERMINED. TRENDING OF ALARM RELATED ISSUES AT CUSTOMER FACILITY FOUND PREVIOUSLY REPORTED ISSUES WHICH WERE CAUSED DUE TO USER ERROR OR MISUNDERSTANDING OF DEVICE AND ALARM FUNCTIONALITY. THERE IS NO TREND OF ALARM ISSUES FOR PU-621RA SN: (B)(6) . ADDITIONAL MODEL INFORMATION: D11 & C2: THE TRANSMITTER WAS USED IN CONJUNCTION WITH THE CNS, BUT DID NOT EXPERIENCE FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: TRANSMITTER - MODEL: ZM-531PA. S/N: NI. APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM WHEN A PATIENT WENT INTO VTAC.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM WHEN A PATIENT WENT INTO VTAC. ATTEMPTS TO OBTAIN FURTHER INFORMATION WERE MADE, BUT NOT PROVIDED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL MODEL INFORMATION: THE TRANSMITTER WAS USED IN CONJUNCTION WITH THE CNS, BUT DID NOT EXPERIENCE FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: TRANSMITTER - MODEL: ZM-531PA, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM WHEN A PATIENT WENT INTO VTAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923018 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSMITTER| TRANSMITTER