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

Model Number CNS-6801A

Device Problems No Audible Alarm (1019); Audible Prompt/Feedback Problem (4020)

Patient Problem Apnea (1720)

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

The patient expired a day after the device failed to alarm.Biomed tested the system afterwards and everything worked fine.Technical support (ts) had the customer print out the investigation documents.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.Concomitant medical device: the following device was used in conjunction with the cns: co2 monitor: 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) did not alarm for apnea.The patient expired a day after the device failed to alarm.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) did not alarm for apnea.According to the customer, the patient was being monitored normally, but when the patient went into respiratory arrest, the cns did not alarm.The patient expired a day after the device failed to alarm.Biomed tested the system afterwards and everything worked fine.Technical support (ts) had the customer print out the investigation documents.Investigation summary: based on the information provided by nka clinical in ticket (b)(4), the bedside monitor did not alarm for respiration due to having a co2 monitor being connected to the bedside though it was not being used to monitor the patient.The central monitoring station (cns) did not alarm for respiration due to the customer not having the parameter for respiration from impedance (rr imp) selected for monitoring on the cns.The printouts provided by the customer is also evidence which shows that rr imp was not being monitored at the time.The operator's manual for pu-6801ra, page 9.21, has information for selecting parameters for review.The root cause for this issue is use error.As this issue has an overall risk score of medium, a capa is not required per corrective action and preventive action process, sop07-003." manufacturer references # 300277611-127934 follow up 001.

Event Description

The customer reported that the central nurse's station (cns) did not alarm for apnea.The patient expired a day after the device failed to alarm.

• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13192042
• MDR Text Key: 286325140
• Report Number: 8030229-2022-02306
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/14/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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: CO2 MONITOR; CO2 MONITOR
• Patient Outcome(s): Death