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

Model Number CNS-6201A

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

Patient Problem Apnea (1720)

Event Date 02/21/2023

Event Type  malfunction  

Event Description

The customer reported that the central nurse's station (cns) did not alarm for the spo2.There was no patient injury reported.

Manufacturer Narrative

The customer reported that the central nurse's station (cns) did not alarm for the spo2.According to the customer, the patient had to be intubated and placed on a bedside monitor.The incident occurred on a zm (b)(4) that was being monitored by this cns.The customer is not sure if the hospital staff lowered or turned off the spo2 alarm so they're requesting for the logs to be reviewed.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: attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied with the following information; female, weight 120 kilos, ethnicity white, race non-latino and pt has sleep apnea.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied with the following information; female, weight 120 kilos, ethnicity white, race non-latino and pt has sleep apnea.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied with the following information; female, weight 120 kilos, ethnicity white, race non-latino and pt has sleep apnea.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for device information: the customer replied with the following information; female, weight 120 kilos, ethnicity white, race non-latino and pt has sleep apnea.

Event Description

The customer reported that the central nurse's station (cns) did not alarm for the spo2.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) did not alarm for the spo2.According to the customer, the patient had to be intubated and placed on a bedside monitor.The incident occurred on a zm 531pa/(b)(6) that was being monitored by this cns.The customer is not sure if the hospital staff lowered or turned off the spo2 alarm so they're requesting for the logs to be reviewed.Investigation summary: the logs were requested from the customer in order to perform an investigation.The customer failed to provide device logs after 5 days in which the logs no longer contained the data relating to the event.A root cause cannot be determined.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 02/28/2023 emailed the customer via microsoft outlook for patient information: the customer replied with the following information; female, weight 120 kilos, ethnicitiy white, race non-latino and pt has sleep apnea.B6 attempt # 1: 02/28/2023 emailed the customer via microsoft outlook for patient information: the customer replied with the following information; female, weight 120 kilos, ethnicitiy white, race non-latino and pt has sleep apnea.B7 attempt # 1: 02/28/2023 emailed the customer via microsoft outlook for patient information: the customer replied with the following information; female, weight 120 kilos, ethnicitiy white, race non-latino and pt has sleep apnea.D10 attempt # 1: 02/28/2023 emailed the customer via microsoft outlook for device information: the customer replied with the following information; female, weight 120 kilos, ethnicitiy white, race non-latino and pt has sleep apnea.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h10 additional manufacturer narrative manufacturer references # (b)(4) follow up 001.

• 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: 16591359
• MDR Text Key: 312209051
• Report Number: 8030229-2023-03431
• 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: 05/23/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• 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
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White