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

Model Number CNS-6801A

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Patient Data Problem (3197)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the arrhythmia strips on this central nurse's station (cns) will be saved but they will save with another patient instead of the patient they are meant for.This issue happens with two different bedsides.The patient information will swap with each other and will continue to do so until either both are discharged or just one.The customer states this happens intermittently and sometimes the fix is discharging both patients, but if the discharging of the patients does not fix the issue, the patient information will just continue to be swapped.No harm or injury 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.(b)(4).

Event Description

The customer reported that the arrhythmia strips on this central nurse's station (cns) will be saved but they will save with another patient instead of the patient they are meant for.This issue happens with two different bedsides.The patient information will swap with each other and will continue to do so until either both are discharged or just one.

Event Description

The customer reported that the arrhythmia strips on this central nurse's station (cns) were saving with the incorrect patient's name on two different bedside monitors (bsms).

Manufacturer Narrative

Investigation summary: the customer reported that the arrhythmia strips on this central nurse's station (cns) were saving with the incorrect patient's name on two different bedside monitors (bsms).No patient harm was reported.Investigation summary: per a previous nkc investigation for a similar incident for the same customer, the root cause is likely related to use error.Duplicate ids were identified in the device log files provided for the cns.Duplicate ids are generated when the data of the bsm-1700 is overwritten by the host monitor during patient transfer as a result of an improper patient transfer procedure.In this instance the central nurse station (cns) keeps the internal id assigned to each patient in each specific tile.When the sending data is overwritten at the bedside monitor, the cns is not able to update the specific tile id, which then causes the caliper measurements to be saved in the wrong patient file.The root cause is likely related to user workflow.The customer was advised of the possible causes and actions to take to prevent recurrence.The following fields contain no information (ni).Emailed customer on 04/20/2021 via microsoft outlook for all items under the no information section.An "unknown" reply was received.A2 a4 a6 additional model information: d10 concomitant medical device: the following device were used in conjunction with the cns: bedside monitors: model: bsm-6501a sn: (b)(6) 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.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11695870
• MDR Text Key: 249685400
• Report Number: 8030229-2021-00228
• 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: 05/26/2023

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: 03/22/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2018
• 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
• Treatment: BSM-6501A; BSM-6501A
• Patient Sex: Male
• Patient Ethnicity: Hispanic