MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Loss of Data (2903); Output Problem (3005); Patient Data Problem (3197)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that multiple bedside monitors (bsms) being monitored at the central nurses station (cns) seemed to be discharged.The patient's live waveforms still appeared on the screen, but their patient id, demographics, and patient history had disappeared.On some of the bedside monitors (bsms), when the patient was re-admitted, the patient's history would come back.However, some patients' history was missing.Technical support (ts) had the bme reboot the cns and re-admit any discharged patients.No patient harm 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.The following fields contains no information (ni), as an attempt to obtain the information were made, but none were provided.A2 - a6.B6.B7.Attempt #1, 05/17/2023 emailed customer for all items under the no information section.No reply was received.Attempt #2, 05/23/2023 emailed customer for all items under the no information section.No reply was received.Attempt #3, 05/24/2023 emailed customer for all items under the no information section.No reply was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: bsms: model #: ni; serial #: ni; device manufacturer data: ni; unique identifier (udi) #: ni; returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that multiple bedside monitors (bsms) being monitored at the central nurses station (cns) seemed to be discharged.The patient's live waveforms still appeared on the screen, but their patient id, demographics, and patient history had disappeared.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that multiple bedside monitors (bsms) being monitored at the central nurses station (cns) seemed to be discharged.The patient's live waveforms still appeared on the screen, but their patient id, demographics, and patient history had disappeared.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that multiple bedside monitors (bsms) being monitored at the central nurses station (cns) seemed to be discharged.The patient's live waveforms still appeared on the screen, but their patient id, demographics, and patient history had disappeared.On some of the bedside monitors (bsms), when the patient was re-admitted, the patient's history would come back.However, some patients' history was missing.Technical support (ts) had the bme reboot the cns and re-admit any discharged patients.No patient harm was reported.Investigation summary: an additional follow-up was sent to the customer on 09/05/2023.The customer has been unresponsive.A definitive root cause could not be determined at this time since we have not received the device logs and could not confirm the complaint.Possible causes of this issue may include an interrupted network connection between the bsm and cns or issues with the input unit connection at the bsm.Network connection issues between the bsm and cns may occur due to loose or damaged network cables from user mishandling, electromagnetic interference from other devices on the customer site if the bsm is on a wireless set-up, or user error with network settings such as duplicate ip addresses or device count limits if the network is segmented.The bsm unit may only be able to send partial data if there are issues with the connection between the input unit and the main unit.Input unit connection issues can occur through user error or hardware component failure.User errors with the input unit may include incorrect workflow for connecting the input unit to the main unit or using incompatible software.The operator's manual and administrator's guides for the bsm include details on how to properly connect the input unit to the main unit and list the minimum software versions needed for compatibility.Hardware component failure on the bsm can occur through physical damage or fluid intrusion from user mishandling, power issues from site outages or surges, or wear-and-tear, which depends on device age and frequency of use.A review of the complaint device's serial number shows that it is 2 years old and has no other related tickets.A review of the customer's complaint history does not show any other similar complaint.The following fields contain no information (ni), as attempts to obtain the information were made, but none were provided.Attempt #1: 05/17/2023 emailed the customer for all items under the no information section.No reply was received.Attempt #2: 05/23/2023 emailed the customer for all items under the no information section.No reply was received.Attempt #3: 05/24/2023 emailed the customer for all items under the no information section.No reply was received.

• Brand Name: CNS-6801A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17125730
• MDR Text Key: 317690531
• Report Number: 8030229-2023-03609
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BSMS; BSMS.