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

Model Number CNS-6801A

Device Problem Data Problem (3196)

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

Event Date 09/05/2023

Event Type  malfunction  

Event Description

The customer reported another instance of heart rate (hr) values from 3 teles not being displayed on the central nurse's station (cns).There was no patient injury reported.

Manufacturer Narrative

The customer reported another instance of heart rate (hr) values from 3 teles not being displayed on the central nurse's station (cns).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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6: attempt # 1: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; kaiser permanent (kp) will not be providing any requested phi/pii.B6: attempt # 1: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; kaiser permanent (kp) will not be providing any requested phi/pii.B7: attempt # 1: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; kaiser permanent (kp) will not be providing any requested phi/pii.D10: attempt # 1: (b)(6) 2022 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: (b)(6) 2022 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3: (b)(6) 2022 emailed the customer via microsoft outlook for device information: the customer replied by stating; kaiser permanent (kp) will not be providing any requested phi/pii.

Event Description

The customer reported another instance of heart rate (hr) values from 3 teles not being displayed on the central nurse's station (cns).There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported another instance of heart rate (hr) values from 3 teles not being displayed on the central nurse's station (cns).There was no patient injury reported.Investigation summary: the root cause for the reported issue was found to be a software deficiency for the g5/g7 monitor viewing the zm transmitter in hi-q view.Countermeasures were added to g5/g7 software version 02-27 to address the issue.The software was released 09/07/2023.The issue was resolved after the g5/g7 software update to version 02-27.Manufacturer references # (b)(4) follow up 001.

• 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: 17818141
• MDR Text Key: 324266431
• Report Number: 8030229-2023-03791
• 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: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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.