BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS

    MDR report key: 8157786 · Received December 12, 2018

    Report

    Report Number
    8030229-2018-00470
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 15, 2018
    Report Date
    July 12, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL NARRATIVE: ON (B)(6) 2018, CUSTOMER CFO REPORTED THAT NK DEVICE (DEVICE MODEL AND SERIAL NUMBER COULD NOT BE OBTAINED) DID NOT ALARM V-TACH AS EXPECTED. THE ISSUE OCCURRED ON THREE SEPARATE OCCASIONS ON THE SAME DAY. NK TECH SUPPORT HAS ATTEMPTED TO CONTACT CUSTOMER BIOMED BUT THE CONTACT NO LONGER WORKED AT THE HOSPITAL. CUSTOMER (B)(6)ANSWERED THE EMAIL ON (B)(6) 2018 AND STATED THAT THE ISSUE WAS RESOLVED. DETAILS WAS NOT PROVIDED. HOWEVER, (B)(6) ALSO STATED THAT V-TACH WAS NOT ALARMING EARLIER ON TUESDAY "THIS WEEK", WHICH WAS ON (B)(6) 2018. ADDITIONAL DETAILS COULD NOT BE OBTAINED. SERVICE REQUESTED: TROUBLESHOOTING. SERVICE PERFORMED: TROUBLESHOOTING. INVESTIGATION RESULT: NO INFORMATION REGARDING THE AFFECTED DEVICE COULD BE OBTAINED. CUSTOMER'S COMPLETE SERVICE HISTORY SHOWS NO OTHER RELEVANT TICKETS. THE ISSUE HAS NOT OCCURRED SINCE THE LAST REPORTED V-TACH ALARM ISSUE ON 11/27/2018. DUE TO UNKNOWN DEVICE, A COMPLETE DEVICE HISTORY COULD NOT BE EVALUATED. AT THIS TIME, THE ROOT CAUSE COULD NOT BE DETERMINED. CORRECTION: D1. BRAND NAME. INCORRECT BRAND NAME SELECTED. D4. MODEL NUMBER. INCORRECT MODEL NUMBER SELECTED. CATALOG NUMBER. INCORRECT MODEL NUMBER SELECTED. UNIQUE IDENTIFIER (UDI) NUMBER. INCORRECT UDI NUMBER SELECTED. F9. APPROXIMATE AGE OF DEVICE. INCORRECT AGE LISTED. NO MODEL/SERIAL PROVIDED, UNABLE TO KNOW AGE OF DEVICE. G5. PMA/510(K) NUMBER. INCORRECT 510K NUMBER LISTED. H4. DEVICE MANUFACTURER DATE. NO MODEL/SERIAL PROVIDED. UNABLE TO DETERMINE DEVICE MANUFACTURER DATE. ADDITIONAL INFORMATION: B4. DATE OF THIS REPORT. F6. DATE USER FACILITY/IMPORTER BECAME AWARE OF THE EVENT. F7. TYPE OF REPORT. F11. DATE REPORT SENT TO FDA. F13. DATE REPORT SENT TO MANUFACTURER. G4. DATE RECEIVED BY MANUFACTURER. G7. TYPE OF REPORT. H2. IF FOLLOW-UP, WHAT TYPE? CORRECTION. ADDITIONAL INFORMATION. H3. DEVICE EVALUATED BY MANUFACTURER? H6. EVENT PROBLEM AND EVALUATION CODES. H10. ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM 3 SEPARATE VTAC EVENTS.

    Additional Manufacturer Narrative · 1

    NIHON KOHDEN CAS REQUESTED THE EVENT LOGS FOR REVIEW, HOWEVER, NO OTHER CONTACT HAS BEEN ABLE TO BE MADE AND THE LOGS HAVE NOT BEEN RECEIVED. ADDITIONALLY, NO MODEL OR SERIAL NUMBER HAS BEEN PROVIDED TO NIHON KOHDEN. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM 3 SEPARATE VTAC EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997504 CNS CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NOT APPLICABLE 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1