MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problems No Display/Image (1183); Electrical /Electronic Property Problem (1198)

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

Event Date 07/31/2022

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) display monitor screen at the nurses station just turned black, the bme tried rebooting the cns, but it remained black.No patient harm was reported.The bme found that it was due to a bad power brick that was going to this display monitor screen and replaced the power brick to the display monitor screen and the display monitor screen is working and issue is resolved.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) display monitor screen at the nurses station just turned black, the bme tried rebooting the cns, but it remained black.No patient harm was reported.The bme found that it was due to a bad power brick that was going to this display monitor screen and replaced the power brick to the display monitor screen and the display monitor screen is working and issue is resolved.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) display monitor screen at the nurses station just turned black, the bme tried rebooting the cns, but it remained black.No patient harm was reported.The bme found that it was due to a bad power brick that was going to this display monitor screen and replaced the power brick to the display monitor screen and the display monitor screen is working and issue is resolved.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) display monitor screen at the nurses station just turned black, the bme tried rebooting the cns, but it remained black.No patient harm was reported.The bme found that it was due to a bad power brick that was going to this display monitor screen and replaced the power brick to the display monitor screen and the display monitor screen is working and issue is resolved.Service performed: on nihon kohden technical services (nk ts) follow up, the customer reported that the issue was caused due to a bad power brick that was going to the display.When the customer used a known working spare power brick the power was restored back to the monitor.Customer was advised to purchase a power brick to replace the degraded one.Investigation summary: the cause of the issue was found to be a degraded elo power brick.This is a non-nk manufactured accessory.The reported issue does not require further investigation through capa process since the issue was caused due to a degraded accessory and not an nk device deficiency/malfunction.Manufacturer narrative b4: date of this report g3: date received by manufacturer g6: type of report h2: if follow-up, what type? h10: additional narrative/data.

• Brand Name: CNS-6201A
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15195598
• MDR Text Key: 305144931
• Report Number: 8030229-2022-03044
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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: 08/23/2022

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2013
• 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