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

Model Number CNS-6801A

Device Problems Communication or Transmission Problem (2896); Wireless Communication Problem (3283)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that a bedside monitor (bsm-6000) dropped off the central nurses station (cns).No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that a bedside monitor (bsm-6000) dropped off the central nurses station (cns).They were unsure when the bsm-6000 was removed from the cns.Biomed would like nkc to review the cns logs.No patient harm was reported.Nkc reviewed the logs, and it was assumed that the communication environment was not good, as they observed a log of failed wlan transport status control transmissions, etc.The following countermeasures are planned for cns-6801a software version 02-24; they believe they will be effective for this event.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 the information were made, but not provided: a2 - a6 b6 - b7 attempt # 1: 04/03/2024 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 04/19/2024 emailed the bme for all information in the ni list above: the bme replied the patient information was unknown.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: bedside monitors (bsm-6000): model #: mu-671ra serial #: (b)(6).Device manufacturer data: 01/21/2017 (jan.21, 2017) unique identifier (udi) #: (b)(4).Returned to nihon kohden: na bedside monitors (bsm-1700): model #: bsm-1733a serial #: (b)(6).Device manufacturer data: 06/28/2016 (june 28, 2016) unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.

• 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: 19115313
• MDR Text Key: 340268998
• Report Number: 8030229-2024-04246
• 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
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• 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: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2017
• 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-1700; BSM-6000