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 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) monitor went out and it will not come back on this happened overnight.The bme replaced the power cord and the power outlet, but the monitor would still not come back on.The bme replaced the monitor with a spare monitor, and it is working correctly.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 contains no information (ni), as an attempt to obtain the information were made, but none were provided.Attempt #1: (b)(6)2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: (b)(6)2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: (b)(6)2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) monitor went out and it will not come back on this happened overnight.The bme replaced the power cord and the power outlet, but the monitor would still not come back on.The bme replaced the monitor with a spare monitor, and it is working correctly.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) monitor went out and it will not come back on this happened overnight.The bme replaced the power cord and the power outlet, but the monitor would still not come back on.The bme replaced the monitor with a spare monitor, and it is working correctly.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) monitor went out and it will not come back on this happened overnight.The bme replaced the power cord and the power outlet, but the monitor would still not come back on.The bme replaced the monitor with a spare monitor, and it is working correctly.No patient harm was reported.Investigation summary: multiple attempts have been made to retrieve the complaint device, but the customer has been unresponsive.A definitive root cause could not be determined since the device was not received for evaluation.The customer was able to replace the screen with a spare.Based on the troubleshooting performed by the customer, possible causes may include cable issues or hardware failure.Cable issues may include loose cables or damaged connectors which can occur through user mishandling.Hardware failure may occur through physical damage or fluid intrusion from user mishandling, power issues from outages or surges, or wear-and-tear which depends on age and frequency of use.Review of the device's serial number does not show any recurrence of this issue.Attempt #1 05/02/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 05/03/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 05/04/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

• 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: 16873391
• MDR Text Key: 314624033
• Report Number: 8030229-2023-03489
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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: 04/10/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• 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
• Treatment: NI.; NI.