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

Model Number CNS-6801A

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the screens at the central nurse's station (cns) are just black.According to the customer, they have 8 screens and half of them have gone down.Technical support (ts) tried to troubleshoot the issue with the customer; however, they were unable to do so.Ts asked the customer to reach out to their biomed for onsite support.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.Attempt # 1: (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 the patient and device information as well as an email.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 the patient and device information as well as an email.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 the patient and device information as well as an email.Attempt # 1: (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 the patient and device information as well as an email.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 the patient and device information as well as an email.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 the patient and device information as well as an email.Attempt # 1: (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 the patient and device information as well as an email.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 the patient and device information as well as an email.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 the patient and device information as well as an email.Attempt # 1: (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 the patient and device information as well as an email.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 the patient and device information as well as an email.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 the patient and device information as well as an email.Attempt # 1: (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 the patient and device information as well as an email.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 the patient and device information as well as an email.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 the patient and device information as well as an email.

Event Description

The customer reported that the screens at the central nurse's station (cns) are just black.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the screens at the central nurse's station (cns) are just black.According to the customer, they have 8 screens and half of them have gone down.Technical support (ts) tried to troubleshoot the issue with the customer; however, they were unable to do so.Ts asked the customer to reach out to their biomed for onsite support.There was no patient injury reported.Investigation summary: multiple attempts were made to further troubleshoot the issue with the customer and collect more information, however, no response was received.The complaint device was also not returned for evaluation.Without further information, and complaint device evaluation, a definitive root cause could not be identified.Manufacturer references # (b)(4) follow up 001.

Event Description

The customer reported that the screens at the central nurse's station (cns) are just black.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: 16453045
• MDR Text Key: 310441979
• Report Number: 8030229-2023-03305
• 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: 05/17/2023

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: 01/30/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• 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