BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 10743978 · Received October 27, 2020

    Report

    Report Number
    8030229-2020-00648
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    October 5, 2020
    Report Date
    February 25, 2021
    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
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2020, THE CUSTOMER AT (B)(6) HOSPITAL & CLINIC, INC REPORTED THE FOLLOWING ISSUE WITH PU-621RA; (B)(6), FROM PATIENT MONITORING: EXPERIENCING ISSUES WITH THE CUSTOMER INSTALLED KVM SET UP ON THE CNS WHERE BOTH SCREENS WERE TURNED OFF BUT THE CNS SOFTWARE APPEARED TO BE RUNNING IN THE BACKGROUND BECAUSE THEY NOTICED THAT THE ALARM INDICATOR WAS FLASHING, AND THEY COULD HEAR ALARMS COMING FROM THE SPEAKER. THE UNIT WAS MONITORING TRANSMITTERS AND BSM'S AT THE TIME. INVESTIGATION SUMMARY: THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE A FAULTY KVM POWER ADAPTER. THE KVM SET UP WAS HOSPITAL INSTALLED AND MAINTAINED BY IT. THE OVERALL RISK OF THIS EVENT, TAKING INTO CONSIDERATION OF SEVERITY AND PROBABILITY, IS "MEDIUM". THE REPORTED ISSUE DOES NOT REQUIRE FURTHER INVESTIGATION THROUGH CAPA PROCESS SINCE THE ISSUE WAS A RESULT OF KVM FAILURE WHICH IS A NON NK ACCESSORY, MAINTAINED BY THE CUSTOMER. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THIS REPORT: B2 B6 B7 D4 LOT # & EXPIRATION DATE D6A & D6B D7B F1 - F14 G4 DEVICE BLA NUMBER G7 G8 H1 SUMMARY REPORT H7 H9 THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6 ADDITIONAL MODEL INFORMATION: D10: MULTIPLE TRANSMITTERS WERE USED IN CONJUNCTION WITH THE CNS, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: TRANSMITTERS - MODEL: NI S/N: NI APPROXIMATE AGE OF THE DEVICE: NI. NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI UNIQUE IDENTIFIER (UDI) #: NI D10: MULTIPLE BSM'S WERE USED IN CONJUNCTION WITH THE CNS, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: BSM'S - MODEL: NI S/N: NI APPROXIMATE AGE OF THE DEVICE: NI. NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI UNIQUE IDENTIFIER (UDI) #: NI ADDITIONAL INFORMATION: B4. DATE OF THIS REPORT G3. DATE RECEIVED BY MANUFACTURER G6. TYPE OF REPORT H2. IF FOLLOW-UP, WHAT TYPE? H6. EVENT PROBLEM AND EVALUATION CODES H10. ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT BOTH SCREENS ON THEIR CENTRAL NURSE'S STATION (CNS) WERE TURNED OFF.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT BOTH SCREENS ON THEIR CENTRAL NURSE'S STATION (CNS) WERE TURNED OFF. THE CUSTOMER ALSO REPORTED THAT THE CNS SOFTWARE APPEARED TO BE RUNNING IN THE BACKGROUND BECAUSE THEY NOTICED THAT THE ALARM INDICATOR WAS FLASHING, AND THEY COULD HEAR ALARMS COMING FROM THE SPEAKER. THE UNIT WAS MONITORING TRANSMITTERS, AND BSM'S AT THE TIME. NO HARM, OR INJURY 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. MULTIPLE TRANSMITTERS WERE USED IN CONJUNCTION WITH THE CNS, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE. MULTIPLE BSM'S WERE USED IN CONJUNCTION WITH THE CNS, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BOTH SCREENS ON THEIR CENTRAL NURSE'S STATION (CNS) WERE TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207812 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 MULTIPLE BEDSIDE MONITOR'S (BSM'S)| MULTIPLE BEDSIDE MONITOR'S (BSM'S)| MULTIPLE TRANSMITTERS| MULTIPLE TRANSMITTERS| MULTIPLE BEDSIDE MONITOR'S (BSM'S)| MULTIPLE TRANSMITTERS