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

Model Number CNS-6201A

Device Problems Application Program Problem (2880); Noise, Audible (3273)

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

Event Date 09/08/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) pc is making a very loud beeping noise.According to the customer, the unit makes 4 beeping noise and then it restarts.Technical support (ts) informed the customer that the issue can either be with the hdd or an internal power issue.Ts assisted the customer in setting up a new unit for patient monitoring.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: patient age or date of birth, sex, weight, ethnicity, and race: attempt # 1: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; no patient involved.Relevant tests/laboratory data: attempt # 1: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; no patient involved.Other relevant history attempt # 1: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; no patient involved.Additional model information: concomitant medical products: the following device was used in conjunction with the cns: bsms: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.

Event Description

The customer reported that the central nurse's station (cns) pc is making a very loud beeping noise.According to the customer, the unit makes 4 beeping noise and then it restarts.There was no patient injury reported.

Event Description

The customer reported that the pc for the central nurse's station (cns) was making a very loud beeping noise.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the pc for the central nurse's station (cns) was making a very loud beeping noise.No patient harm was reported.Investigation summary: the reported device was sent in for repair.During the evaluation of the reported unit nihon kohden technical support (nk ts) found that the unit was not able to boot.The operating system was not found.The hdds were replaced to resolve the issue.Based on the error, it is likely that the operating system had become corrupted.Corruption of the hard drive(s) can lead to failures in operation.The most common causes for software corruption are ungraceful exits due to use error or power loss.Improper system shutoff is likely to corrupt files and software while performing operations.There is no evidence the corruption was related to the design or manufacturing of the device.The following fields contain no information (ni), as an attempt to obtain the information was made, but not provided: attempt # 1: (b)(6) 2022 emailed the customer via microsoft outlook for all information in the ni list above: the customer replied, stating that the patient was being discharged at the time and there was no patient involvement.Additional model information: concomitant medical device: the following device was used in conjunction with the cns: bsms: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: ni.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15563576
• MDR Text Key: 307034108
• Report Number: 8030229-2022-03106
• 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: 10/25/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• 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
• Treatment: BEDSIDE MONITORS (BSMS)