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 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the bedside monitor (bsm) was being monitored and locally filed on this central nurse's station (cns).Patient record was showing arrythmia recall alarms of various types of arrythmia events.During the time of these events, the alarm did not go off.Within the full disclosure, there was no particular color that are marked with arrythmia events, and the arrythmia traces do not match the full disclosure for the patient.The patient name and id are the same, but the arrythmia traces do not match.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.Additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the cns.Bedside monitor model: bsm-6301a sn: (b)(6) device manufacturer date: 10/09/2018 unique identifier (b)(4) returned to nihon kohden: not returned.Bedside monitor model: bsm-1733a sn: (b)(6) device manufacturer date: 10/19/2020 unique identifier (b)(4) returned to nihon kohden: not returned.Bsm-6301a sn (b)(6) bsm-1733a sn (b)(6).

Event Description

The biomedical engineer (bme) reported that the bedside monitor (bsm) was being monitored and locally filed on this central nurse's station (cns).Patient record was showing arrythmia recall alarms of various types of arrythmia events.During the time of these events, the alarm did not go off.Within the full disclosure, there was no particular color that are marked with arrythmia events, and the arrythmia traces do not match the full disclosure for the patient.The patient name and id are the same, but the arrythmia traces do not match.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) was being monitored and locally filed on this central nurse's station (cns).Patient record was showing arrythmia recall alarms of various types of arrythmia events.During the time of these events, the alarm did not go off.Within the full disclosure, there was no particular color that are marked with arrythmia events, and the arrythmia traces do not match the full disclosure for the patient.The patient name and id are the same, but the arrythmia traces do not match.No patient harm was reported.Investigation conclusion: a root cause of the reported condition could not be determined.Investigation concluded that the possible causes may be related to the settings used for arrhythmia recall and arrhythmia alarms.Additionally, possibles causes could be due to corruption of the arrhythmia recall data.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.Attempt #1 11/02/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 11/16/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 11/20/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the cns.Bedside monitor model: bsm-6301a sn: (b)(6) device manufacturer date: 10/09/2018 unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Bedside monitor model: bsm-1733a sn: (b)(6) device manufacturer date: 10/19/2020 unique identifier (udi) #: (b)(4) returned to nihon kohden: not returned.

Event Description

The biomedical engineer (bme) reported that the bedside monitor (bsm) was being monitored and locally filed on this central nurse's station (cns).Patient record was showing arrythmia recall alarms of various types of arrythmia events.During the time of these events, the alarm did not go off.Within the full disclosure, there was no particular color that are marked with arrythmia events, and the arrythmia traces do not match the full disclosure for the patient.The patient name and id are the same, but the arrythmia traces do not match.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: 18223538
• MDR Text Key: 329435525
• Report Number: 8030229-2023-03881
• 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: 02/26/2024

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: 10/30/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2020
• 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: BSM-1733A SN (B)(6); BSM-1733A SN (B)(6).; BSM-6301A SN (B)(6); BSM-6301A SN (B)(6)