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

Model Number CNS-6801A

Device Problems Loss of Data (2903); Data Problem (3196)

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

Event Date 08/22/2023

Event Type  malfunction  

Event Description

The customer reported that patients are dropping off the central nurse's station (cns) and the history is being deleted.There was no patient injury reported.

Manufacturer Narrative

The customer reported that patients are dropping off the central nurse's station (cns) and the history is being deleted.According to the customer, the patients are admitted then randomly they will be discharged and patient not found will be displayed in the patient's name area and all history will be deleted for the patient.The customer is sending the logs to be reviewed.There was no patient injury 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.

Manufacturer Narrative

Details of complaint: the customer reported that patients are dropping off the central nurse's station (cns) and the history is being deleted.According to the customer, the patients are admitted then randomly they will be discharged and patient not found will be displayed in the patient's name area and all history will be deleted for the patient.The customer is sending the logs to be reviewed.There was no patient injury reported.Investigation summary: the logs were reviewed by nihon kohden (nk) dhs, and they did not see any evidence in the unitfied gateway (ug) log that the enterprise gateway (eg) was behind the random discharge issue.Nkc investigated the central nurse's station (cns) and the bedside monitor (bsm) logs, and it was identified that the bed was discharged from the cns.It is likely that a user of the cns had inadvertently discharged the monitored bed.After a discharge action, an admit action of the bed was also performed on the cns, which is likely done to re-admit the discharged bed.Based on the available information, the most probable cause of the discharge issue is user error.Review data and patient history of a discharged patient would still be available on the cns until 120 hrs after a patient was discharged in the "discharged patient list'.It is unknown why the patient data could no longer be found by customer even though it was still within 120 hrs after the discharge.The cause of the patient's history being deleted is unknown.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 09/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 09/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 09/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 09/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 09/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 09/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.D10 attempt # 1: 09/05/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 09/07/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 09/13/2023 emailed the customer via microsoft outlook for device information: no reply was received.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h10 additional manufacturer narrative.Manufacturere references # (b)(4) follow up 001.

Event Description

The customer reported that patients are dropping off the central nurse's station (cns) and the history is being deleted.There was no patient injury 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: 17777794
• MDR Text Key: 323797132
• Report Number: 8030229-2023-03776
• Device Sequence Number: 1
• Product Code: MHX
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• 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
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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: NI.; NI.