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

Model Number CNS-6801A

Device Problems Connection Problem (2900); Output Problem (3005); Incomplete or Inadequate Connection (4037)

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

Event Date 07/28/2022

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the bed tiles are randomly disappearing from the all beds screen on the central nurse's station (cns).There are many teams involved in supporting these issues, and the clinical team who visited vidant reported that many users were un-docking the bsm-1700 without the proper procedure.Based on the investigation of the bsm-1700 logs by the nihon kohden engineers, qa also learned that the bsm-1700's were not properly un-docked from the bsm-6000's.No patient harm was 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.Additional device information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1 10/06/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 10/31/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The biomedical engineer (bme) reported that the bed tiles are randomly disappearing from the all beds screen on the central nurse's station (cns).There are many teams involved in supporting these issues, and the clinical team who visited vidant reported that many users were un-docking the bsm-1700 without the proper procedure.Based on the investigation of the bsm-1700 logs by the nihon kohden engineers, qa also learned that the bsm-1700's were not properly un-docked from the bsm-6000's.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the bed tiles were randomly disappearing from the all beds screen at the central nurse's station (cns).No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the bed tiles were randomly disappearing from the all beds screen at the central nurse's station (cns).No patient harm was reported.Investigation summary: the customer sent in the device logs for evaluation.The investigation of the device logs from the reported cns found that the customer was not using the correct procedure when undocking the input units from the main bsm.The customer was removing the input units while data was being sent, which caused the data being sent to the cns to become corrupt.It was concluded that this was the cause of the issue.As described in the operator's manual, data may be corrupted if the input units is undocked while data is being sent.Therefore, the root cause is related to use error and user education.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided.Attempt #1 10/06/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 10/30/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: concomitant medical device: the following devices were used in conjunction with the cns: bedside monitors (bmss): model #: ni serial #: 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: 15720597
• MDR Text Key: 307695284
• Report Number: 8030229-2022-03139
• 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: 10/24/2023

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 11/03/2022
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2017
• 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: BEDSIDE MONITORS (BMSS)