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

Model Number CNS-6801A

Device Problems Application Program Problem (2880); Wireless Communication Problem (3283)

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

Event Date 01/24/2022

Event Type  malfunction  

Event Description

The customer reported that a couple of their gz transmitter tiles went blank on the central nurse's station (cns) screen.The customer further explained that the tiles went blank not showing any tele names, patient names, and not displaying waveforms.No harm or injury was reported.The cns did not display any error messages when this issue occurred.

Manufacturer Narrative

The customer reported that a couple of their gz transmitter tiles went blank on the central nurse's station (cns) screen.The customer further explained that the tiles went blank not showing any tele names, patient names, and not displaying waveforms.No harm or injury was reported.The cns did not display any error messages when this issue occurred.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.Additional device information: concomitant medical device: the following device(s) were used in conjunction with the cns: gz transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.

Event Description

The customer reported that the gz transmitters were dropping off the central nurse's station (cns).The cns was not displaying tele names, patient names, or waveforms, as well as no error messages.No harm or injury was reported.

Manufacturer Narrative

Details of complaint: the customer reported that the gz transmitters were dropping off the central nurse's station (cns).The cns was not displaying tele names, patient names, or waveforms, as well as no error messages.No patient harm was reported.Investigation summary: the issue of the gz transmitters dropping off the cns could not be confirmed as the customer did not provide the required log files for investigation.As the reported device was not returned for evaluation, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.As the gz transmitters communicate with the cns via the hospitals access points, gz transmitters dropping off the cns is likely related to an isolated event relating to the customer's wireless network.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.Attempt #1: 02/14/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 02/16/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 02/18/2022 emailed customer via microsoft outlook for all items under the no information section.The customer replied that the requested information was unknown.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: gz transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.

• 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: 13579304
• MDR Text Key: 289468484
• Report Number: 8030229-2022-02519
• 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: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• 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: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2018
• 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: GZ TRANSMITTERS; GZ TRANSMITTERS