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

Model Number CNS-6801A

Device Problems Device Displays Incorrect Message (2591); Audible Prompt/Feedback Problem (4020)

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

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that they had 2 patients on the central nurse's station (cns) that did not alarm for v tachy as the unit showed them as a vpc.According to the customer, the first patient had a 7-beat run and the second patient had a 10-beat.The customer will complete the event investigation so that the clinical team can review these alarms.There was no patient injury 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.

Event Description

The customer reported that they had 2 patients on the central nurse's station (cns) that did not alarm for v tachy as the unit showed them as a vpc.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that 2 patients, monitored at the central nurse's station (cns), experienced events that alarmed as vpc instead of the expected v tach.The first patient had a 7-beat run, and the second patient had a 10-beat run.No patient harm was reported.Investigation summary: a nihon kohden representative provided the investigation guide to assist the customer with collecting information for investigation.The information needed for the investigation include alarm settings, waveform printouts, device logs, date and time of the events.The above information is currently unavailable.Separately, the customer was contacted three times regarding patient and device information for the reported events.No responses were received.There is insufficient information available for investigation.There is no indication of a device malfunction.A review of the service history for this cns shows this is an isolated incident with no recurrence history.Attempt # 1: 07/08/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for kaitlynn to call me back with the patient and device information as well as an email address.Attempt # 2: 07/13/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for kaitlynn to call me back with the patient and device information as well as an email address.Attempt # 3 07/27/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for kaitlynn to call me back with the patient and device information as well as an email address.

Event Description

The customer reported that 2 patients, monitored at the central nurse's station (cns), did not alarm for v tachy, but instead reported it as a vpc.There was no patient injury 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15148324
• MDR Text Key: 304890294
• Report Number: 8030229-2022-03007
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• 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