MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number	CNS-9700A
Medical Device Problem Codes	No Audible Alarm (1019); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient experienced a vtac for approximately 4-6 minutes.The system set a yellow alarm instead of the expected red warning alarm.Technical support (ts) asked the customer to please provide the patient strip, a screen shot of the vtac event (if possible) and the alarm history.The application specialist is working with the customer to investigate the issue.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.
Event or Problem Description
The customer reported a possible missed vtac event.According to the customer, the patient went into a vtac condition, but the central nurse's station (cns) did not set/ sound an alarm.There was no patient injury reported.
Event or Problem Description
The customer reported a possible missed vtac event at the central nurse's station (cns).The patient went into a vtac condition, but the cns did not sound an alarm.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported a possible missed vtac event at the central nurse's station (cns).The patient went into a vtac condition, but the cns did not sound an alarm.The patient experienced a vtac for approximately 4-6 minutes and the system sent a yellow alarm instead of the expected red warning alarm.The device was in patient use.Investigation summary: as no devices were returned and no logs were provided for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.The printouts reviewed by nka clinical shows areas that are missing data.The customer stated that they were aware of the devices failing status and age and were looking to replace the unit in the near future.The device was installed in 02/2011 with no history of servicing.The missed event and missing data may be related to the device's failing hardware.Hardware failure could come as a result of physical damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or device placement.Electrical damage could occur during a power outage or power surge.Wear and tear due to aging or frequency of use can gradually degrade components.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 11/04/2021 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 11/08/2021 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3 11/10/2021 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Corrected information: corrected the "details of complaint" to reflect that the device was in patient use.
Event or Problem Description
The customer reported a possible missed vtac event at the central nurse's station (cns).The patient went into a vtac condition, but the cns did not sound an alarm.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported a possible missed vtac event at the central nurse's station (cns).The patient went into a vtac condition, but the cns did not sound an alarm.The patient experienced a vtac for approximately 4-6 minutes and the system sent a yellow alarm instead of the expected red warning alarm.The device was not in patient use.Investigation summary: as no devices were returned and no logs were provided for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.The printouts reviewed by nka clinical shows areas that are missing data.The customer stated that they were aware of the devices failing status and age and were looking to replace the unit in the near future.The device was installed in 02/2011 with no history of servicing.The missed event and missing data may be related to the device's failing hardware.Hardware failure could come as a result of physical damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or device placement.Electrical damage could occur during a power outage or power surge.Wear and tear due to aging or frequency of use can gradually degrade components.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 11/04/2021 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 11/08/2021 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3 11/10/2021 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.

• Brand Name: CNS-9700A
• Common Device Name: 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: 12866133
• Report Number: 8030229-2021-01996
• Device Sequence Number: 3547552
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K023475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2023

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
• Operator of Device: Health Professional
• Device Model Number: CNS-9700A
• Device Catalogue Number: MU-971RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 09/12/2023; 09/12/2023
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 09/25/2023; 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.; NI.
• Patient Sex: Unknown