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

Model Number CNS-6801A

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 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's stations (cnss) are not alarming vtach for 3 bedside monitors (bsms).Nihon kohden clinical applications specialist (cas) reviewed the event printout information concerning non-audible vt alarms according to the customer.The ecg tracing reveals a vt event at 10:01.The arrhythmia recall information shows a vpc run (warning) and vt alarm (crisis) at the exact time of the event.According to tech support (ts), the customer stated that several vt events occurred without audible alarms.Only 1 incident was submitted.Cas advised ts that the "alarm history" was not submitted.The alarm history would verify if the silence alarm key had been activated.Ts was to verify information with the client.On 11/06/2023, they connected with wendy, the monitor tech, to get better clarification of the complaint.The customer stated that they recently received the new cns in the monitor room and the default settings are not reflecting the needs of this particular area.They asked if someone would be able to reconfigure the setting back to the original defaults.That was their main complaint.Cas asked if it was possible that the alarm could have been silenced by the staff and they were not sure.The staff have the ability to silence alarms.Discussed the findings and conversation with nk technical service account manager (tsam) who stated that they would follow up with the bme.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.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 11/03/2023 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 stations (cnss) are not alarming vtach for 3 bedside monitors (bsms).Nihon kohden clinical applications specialist (cas) reviewed the event printout information concerning non-audible vt alarms according to the customer.The ecg tracing reveals a vt event at 10:01.The arrhythmia recall information shows a vpc run (warning) and vt alarm (crisis) at the exact time of the event.According to tech support (ts), the customer stated that several vt events occurred without audible alarms.Only 1 incident was submitted.Cas advised ts that the "alarm history" was not submitted.The alarm history would verify if the silence alarm key had been activated.Ts was to verify information with the client.On 11/06/2023, they connected with (b)(6), the monitor tech, to get better clarification of the complaint.The customer stated that they recently received the new cns in the monitor room and the default settings are not reflecting the needs of this particular area.They asked if someone would be able to reconfigure the setting back to the original defaults.That was their main complaint.Cas asked if it was possible that the alarm could have been silenced by the staff and they were not sure.The staff have the ability to silence alarms.Discussed the findings and conversation with nk technical service account manager (tsam) who stated that they would follow up with the bme.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurse's stations (cnss) were not alarming vtach for 3 bedside monitors (bsms).No patient harm was reported.Investigation summary: nihon kohden (nk) clinical applications specialist (cas) reviewed the event printout information concerning non-audible vt alarms.The ecg tracing revealed a vt event at 10:01.The arrhythmia recall information showed a vpc run (warning) and vt alarm (crisis) at the exact time of the event.Several vt events occurred without audible alarms.Only 1 incident was submitted.Cas advised ts that the "alarm history" was not submitted.The alarm history would verify if the silence alarm key had been activated.On 11/06/2023, the monitor tech stated that they recently received the new cns in the monitor room and the default settings did not reflect the needs of this monitoring area and wanted to have someone reconfigure the settings back to the original defaults.The customer was unsure if the alarm was silenced by a staff member.Nk received the cns logs from the customer on 12/19/2023 and they were reviewed by nkc.Nkc could not determine a root cause because the logs did not contain information from the occurrence date.The logs only showed information from 11/27/2023 forward.Possible causes of the cns not making an audible alarm may be related to the arrhythmia alarm and arrhythmia recall settings, or alarm volume settings, or user interaction such as silencing an alarm.Review of the complaint device's serial number does not show recurrence or other similar complaints.The following fields contains no information (ni), as an attempt to obtain the information was made, but could not be provided.Attempt #1 11/03/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded, but stated they would not be able to provide the reqested information.

Event Description

The biomedical engineer (bme) reported that the central nurse's stations (cnss) were not alarming vtach for 3 bedside monitors (bsms).No patient harm was reported.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18253076
• MDR Text Key: 330671406
• Report Number: 8030229-2023-03916
• 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: 02/28/2024

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2021
• 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