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

Model Number CNS-6801A

Device Problems Communication or Transmission Problem (2896); Data Problem (3196)

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

Event Date 12/23/2023

Event Type  malfunction  

Event Description

The customer reported that the patient disappeared after wlan transport.There was no patient injury reported.

Manufacturer Narrative

The customer reported that the patient disappeared after wlan transport.According to the customer, when the bedside monitor (bsm) has its 1700 undocked, the 1700 can be seen at the central nurse's station (cns); however, when the 1700 is redocked the bsm will exit wlan fine, but at the cns, the admit button will display as if the patient was discharged.When the same bsms are being monitored by another cns, the issue does not occur.The customer changed out the cns with a spare.The customer will provide 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 04/02/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to provide the requested information.B6 attempt # 1: 04/02/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to provide the requested information.Attempt # 1: 04/02/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to provide the requested information.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the cns: bsm: model #: ni serial #: (b)(6).Device manufacturer date: ni unique identifier (udi) #: (b)(4).Returned to nihon kohden: no additional model information: d10 concomitant medical device: the following device was used in conjunction with the cns: rns: model #: ni serial #: (b)(6).Device manufacturer date: ni unique identifier (udi) #: (b)(4).Returned to nihon kohden: no.

• 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: 18528289
• MDR Text Key: 333054585
• Report Number: 8030229-2024-04023
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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: 12/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• 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: BSM; RNS