BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 10025709 · Received May 5, 2020

    Report

    Report Number
    8030229-2020-00251
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 12, 2020
    Report Date
    May 11, 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
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2020, THE MONITOR TECHNICIAN AT (B)(6) CORP REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) (PU-621RA SN: (B)(6) LOST COMMUNICATION WITH 5 TELEMETRY DEVICES. SERVICE REQUESTED/PERFORMED: NKA TECHNICAL SUPPORT (TS) ADVISED THE MONITOR TECH TO SWAP THE TELEMETRY UNITS FROM THE 5 PATIENTS UNTIL SOMEONE WAS ABLE TO TROUBLESHOOT. THE CUSTOMER WAS TO ALERT THE PROPER STAFF. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER, RECEIVING NO RESPONSE. INVESTIGATION SUMMARY: THE UNIT WAS NOT RETURNED AND NO NKA EVALUATION WAS PERFORMED. DUE TO THE LACK OF CUSTOMER RESPONSE, INFORMATION IS LIMITED, AND THE ROOT CAUSE IS NOT KNOWN. NO PATTERN OF COMMUNICATION LOSS HAS BEEN REPORTED FOR THE UNIT. THE OVERALL RISK IS DETERMINED TO BE LOW. THE REPORTED ISSUE DOES NOT REQUIRE FURTHER INVESTIGATION THROUGH THE CAPA PROCESS. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THE MDR REPORT: D4: LOT# & EXPIRATION DATE. G4: DEVICE BLA NUMBER. 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 MONITOR TECH REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS IN COMMUNICATION LOSS WITH 5 TELEMETRY TRANSMITTERS. NIHON KOHDEN TECHNICAL SUPPORT CALLED THE MONITOR TECH BUT THEY WERE NOT AVAILABLE, AND THEY SPOKE TO ANOTHER MONITOR TECH BUT THEY WERE NOT AWARE OF ANY ISSUES. WE HAVE CONTACTED THEIR IT / IS PERSONNEL TO CONFIRM IF THE ISSUE WAS RESOLVED, BUT THEY HAVE NOT RESPONDED BACK EITHER. NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    THE MONITOR TECH REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS IN COMMUNICATION LOSS WITH 5 TELEMETRY TRANSMITTERS. NIHON KOHDEN TECHNICAL SUPPORT CALLED THE MONITOR TECH BUT THEY WERE NOT AVAILABLE, AND THEY SPOKE TO ANOTHER MONITOR TECH BUT THEY WERE NOT AWARE OF ANY ISSUES. WE HAVE CONTACTED THEIR IT / IS PERSONNEL TO CONFIRM IF THE ISSUE WAS RESOLVED, BUT THEY HAVE NOT RESPONDED BACK EITHER. NO PATIENT HARM 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. CONCOMITANT MEDICAL DEVICE: TELEMETRY TRANSMITTER WERE BEING USED IN CONJUNCTION WITH THE CNS; HOWEVER THE MODEL AND SERIAL NUMBER INFORMATION FOR THE TELEMETRY TRANSMITTERS WERE REQUESTED BUT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE MONITOR TECH REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS IN COMMUNICATION LOSS WITH 5 TELEMETRY TRANSMITTERS. NIHON KOHDEN TECHNICAL SUPPORT CALLED THE MONITOR TECH BUT THEY WERE NOT AVAILABLE, AND THEY SPOKE TO ANOTHER MONITOR TECH BUT THEY WERE NOT AWARE OF ANY ISSUES. WE HAVE CONTACTED THEIR IT / IS PERSONNEL TO CONFIRM IF THE ISSUE WAS RESOLVED, BUT THEY HAVE NOT RESPONDED BACK EITHER. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487169 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 TELEMETRY TRANSMITTERS.| TELEMETRY TRANSMITTERS.| TELEMETRY TRANSMITTERS