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

Model Number CNS-6801A

Device Problems No Audible Alarm (1019); Protective Measures Problem (3015); Data Problem (3196)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

The customer reported that this central nurse's station (cns) is not alarming for tachy/brady for some patients on transmitters.There was no patient injury reported.

Manufacturer Narrative

The customer reported that this central nurse's station (cns) is not alarming for tachy/brady for some patients on transmitters.The customer is also unable to pull up arrhythmia recall for these patients at all.The unit is being exchanged as it is only a few months old.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for (b)(6) to call me back with this information.Attempt # 3 (b)(6) 2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for (b)(6) to call me back with this information.B6 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for (b)(6) to call me back with this information.Attempt # 3 (b)(6) 2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for (b)(6) to call me back with this information.B7 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for (b)(6) to call me back with this information.Attempt # 3 (b)(6) 2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for (b)(6) to call me back with this information.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the cns: transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the cns: org: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.

• 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: 17262928
• MDR Text Key: 318471301
• Report Number: 8030229-2023-03620
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• 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
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2022
• 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: ORG; TRANSMITTERS