BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 9419818 · Received December 5, 2019

    Report

    Report Number
    8030229-2019-00698
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    November 5, 2019
    Report Date
    March 12, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INFORMATION: ON (B)(6) 2019, CUSTOMER AT SAN LUIS VALLEY REGIONAL MEDICAL CENTER REPORTED SIGNAL LOSS ON TRANSMITTER ZM-920PA WITH SERIAL# (B)(6) , ALONG WITH ONE MORE TELEMETRY DEVICE FOR WHICH DETAILS WERE NOT PROVIDED. SUCH REPORTS ARE ADDRESSED UNDER CAPA-18-033. SERVICE REQUESTED: ASSISTANCE IN TROUBLESHOOTING. SERVICE PERFORMED: NKTS COULD DUPLICATE THE ISSUE AND ASSISTED IN TROUBLESHOOTING. THE ISSUE WAS RESOLVED BY REPLACING THE OLD POWER SUPPLIES OF BOTH THE TELEMETRY DEVICES. SINCE USER IS RESPONSIBLE FOR CHANGING OLD BATTERIES OF TELEMETRY DEVICES. THE NATURE OF THE COMPLAINT WILL BE IDENTIFIED AS USER ERROR. INVESTIGATION CONCLUSION: ROOT CAUSE OF THE ISSUE WAS IDENTIFIED TO BE USER ERROR DUE TO BAD BATTERIES ON THE TELEMETRY DEVICES. WARRANTY OF THE DEVICE EXPIRED ON 02/08/2017. ADDITIONAL DEVICE INFORMATION: D11 & C2: THE FOLLOWING DEVICES WERE BEING USED IN CONJUNCTION WITH THE CNS: TRANSMITTER IN ROOM 211: MODEL NUMBER: ZM-920PA, SERIAL NUMBER: (B)(6) . TRANSMITTER IN ROOM 212: NO MODEL NUMBER AND SERIAL NUMBER WAS PROVIDED . ORG: MODEL NUMBER: ORG-9700. SERIAL NUMBER: (B)(6) .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CENTRAL NURSE'S STATION (PU-681RA) WENT INTO SIGNAL LOSS WITH TWO TELEMETRY DEVICES. NO CONSEQUENCE OR IMPACT TO THE PATIENTS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE CENTRAL NURSE'S STATION (PU-681RA) WENT INTO SIGNAL LOSS WITH TWO TELEMETRY DEVICES. NO CONSEQUENCE OR IMPACT TO THE PATIENTS. THE CUSTOMER INDICATED THAT THE SIGNAL LOSS ONLY OCCURS WHEN THE TRANSMITTER IS NEXT TO PATIENT BED OR WHEN THE PATIENT GOES TO THE RESTROOM. SIGNAL LOSS WAS IN ROOM 211 AND 212. SUGGESTED THE CUSTOMER TO CHANGE OUT THE OLD STYLE POWER SUPPLIES AND ONCE THE NEW POWER SUPPLIES INSTALLED, THERE HAVE NOT BEEN ANY SIGNAL LOSS ISSUES. 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. ADDITIONAL DEVICE INFORMATION: THE FOLLOWING DEVICES WERE BEING USED IN CONJUNCTION WITH THE CNS: TRANSMITTER IN ROOM 211: MODEL NUMBER: ZM-920PA, SERIAL NUMBER: (B)(4). TRANSMITTER IN ROOM 212: NO MODEL NUMBER AND SERIAL NUMBER WAS PROVIDED. ORG: MODEL NUMBER: ORG-9700, SERIAL NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CENTRAL NURSE'S STATION (PU-681RA) WENT INTO SIGNAL LOSS WITH TWO TELEMETRY DEVICES. NO CONSEQUENCE OR IMPACT TO THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214327 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 TELESORG| TELESORG