MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problems Communication or Transmission Problem (2896); Loss of Data (2903); Inappropriate or Unexpected Reset (2959)

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

Event Date 05/19/2023

Event Type  malfunction  

Event Description

The customer reported that they have been experiencing multiple issues with this central nurse's station (cns).According to the customer, everything in the er went into communication loss (comm loss).The cns then spontaneously rebooted and when it came back up, there were some beds missing.There was no patient injury reported.

Manufacturer Narrative

The customer reported that they have been experiencing multiple issues with this central nurse's station (cns).According to the customer, everything in the er went into communication loss (comm loss).The cns then spontaneously rebooted and when it came back up, there were some beds missing.Rooms are randomly dropping off the cns ever since the new 05-20 software.The customer requested on site service.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 they have been experiencing multiple issues with this central nurse's station (cns).According to the customer, everything in the er went into communication loss (comm loss).The cns then spontaneously rebooted and when it came back up, there were some beds missing.Rooms are randomly dropping off the cns ever since the new 05-20 software.The customer requested on site service.There was no patient injury reported.Investigation summary: technical support (ts) followed up with the onsite technician and the customer on 09/12/2023, 09/13/2023 and 09/14/2023 asking for an update on the reported issue, however, neither responded.Despite our follow up attempts, no further information was reported.Due to lack of response from the onsite technician and the customer, a definitive root cause could not be determined.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h11 additional manufacturer narrative.Manufacturer references # (b)(4), follow up 001.

Event Description

The customer reported that they have been experiencing multiple issues with this central nurse's station (cns).According to the customer, everything in the er went into communication loss (comm loss).The cns then spontaneously rebooted and when it came back up, there were some beds missing.There was no patient injury reported.

• Brand Name: CNS-6201A
• 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: 17107671
• MDR Text Key: 317220627
• Report Number: 8030229-2023-03600
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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: 03/21/2024

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2015
• 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