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

Model Number CNS-6801A

Device Problems Loss of Data (2903); Patient Data Problem (3197)

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

Event Date 04/04/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) is removing a room intermittently, it does have a patient on in the room when it removed the room.In order to see the device again the bme had to reset the bedside monitor under monitor settings/monitor bed settings, and do a start monitor on the bedside monitor.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) is removing the room intermittently, it did have a patient on in the room when it removed the room.In order to see the device again the bme had to reset the bedside monitor under monitor settings/monitor bed settings, and do a start monitor on the bedside monitor.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: 04/10/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 04/12/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 04/27/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.B6 04/10/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 04/12/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 04/27/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.B7 04/10/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 04/12/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 04/27/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.D10 attempt #1 04/10/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 04/12/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 04/27/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Manufacturer Narrative

Complaint summary: the biomedical engineer (bme) reported that the central nurse's station (cns) is removing the room intermittently, it did have a patient on in the room when it removed the room.In order to see the device again the bme had to reset the bedside monitor under monitor settings/monitor bed settings, and do a start monitor on the bedside monitor.No patient harm was reported.Investigation summary: a definitive root cause could not be determined from the device logs but based on the customer's eg logs and network capture data, possible causes include incomplete insertion of the bsm-1700 input unit when using wlan transport or loss of network connection for the bsm-1700 due to the customer's wireless network environment.Nkc developed a countermeasure to address this issue through the bsm-1700 software update to version 02-68.Review of the complaint device's serial number does not show other similar complaints.Review of the customer's complaint history does not show recurrence after the software update which was released 10/06/2023.Additional information: b4 date of this report d10 suspect medical device 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.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) is removing a room intermittently, it does have a patient on in the room when it removed the room.In order to see the device again the bme had to reset the bedside monitor under monitor settings/monitor bed settings, and do a start monitor on the bedside monitor.No patient harm was reported.

• 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: 16840577
• MDR Text Key: 314534211
• Report Number: 8030229-2023-03488
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

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: 04/04/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2018
• 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