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

Model Number CNS-6201A

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Protective Measures Problem (3015)

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

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) did not alarm for bradycardia.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.The following fields are not applicable (na) to the mdr report: b2, d4 lot number & expiration, d6a - d6b, d7b, f1 - f14, g4 device bla number g5, g7, h2, h7, and h9.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6.B6 - b7.D10 concomitant medical device.Attempt #1 11/20/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the patient and additional device information as requested.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) did not alarm for bradycardia.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) did not alarm for bradycardia.No patient harm was reported.Investigation conclusion: review of the strips by nka clinical indicates that the bedside monitor should have triggered an alarm.To confirm if the device alarmed or not, the device logs would need to be analyzed.The customer was contacted to provide the device logs, but device logs were not provided in a timely manner.Due to the delay, the relevant data would no longer be present in the logs and the issue could not be confirmed.As such, it is likely that the alarm may have been triggered but was erroneously silenced by a clinician.A serial number review of the reported device does not reveal additional related complaints.Complaint history review of the customer's account does not reveal similar complaints for the reported device.The following fields are not applicable (na) to the mdr report: the following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.D10 concomitant medical device attempt #1: 11/20/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the patient and additional device information as requested.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) did not alarm for bradycardia.No patient harm was reported.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18253093
• MDR Text Key: 329708870
• Report Number: 8030229-2023-03918
• Device Sequence Number: 1
• Product Code: MHX
• 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: 02/16/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2017
• 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