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

Model Number CNS-6801A

Device Problems Computer Software Problem (1112); Unintended Application Program Shut Down (4032)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) shut down on its own and did not restart.Bme reported he tried to power it back on, sees the error codes on bootup 4f and 3b, but the cns would not boot up, it does not show the boot screen.There are amber lights on the cns tower and monitor, so there is power to the units.When the bme tried to power it on, the status lamp illuminates amber.After it cycles through the bit, it settles on 3b for a while before it stops trying to boot up.The fans are on, but nothing is coming up and it does not seem to finish booting.Bme tried to power on the screen, but it states "no sync" then goes right back to standby mode.Bme reported there is another remote nurse station (rns) monitoring the patients who are also on telemetry devices.No patient harm was reported.Nihon kohden continues to investigate the reported event.Nihon kohden repair center evaluated the returned cns model pu-681ra serial number (b)(6) and confirmed the reported problem that the cns did not boot up when powered on and the main board and the fan was running very noisy.Pu-681ra was received with physical damage on the internal chassis which was bent.The hard disc drives were damaged.Due to the multiple damages, this unit is unable to be repaired.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 the information were made, but not provided: a2 - a6 b6 - b7 d10 attempt # 1: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received and biomed was unable to provide the requested information above.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) shut down on its own and did not restart.Bme reported he tried to power it back on, sees the error codes on bootup 4f and 3b, but the cns would not boot up, it does not show the boot screen.There are amber lights on the cns tower and monitor, so there is power to the units.When the bme tried to power it on, the status lamp illuminates amber.After it cycles through the bit, it settles on 3b for a while before it stops trying to boot up.The fans are on but nothing is coming up and it does not seem to finish booting.Bme tried to power on the screen, but it states "no sync" then goes right back to standby mode.Bme reported there is another remote nurse station (rns) monitoring the patients who are also on telemetry devices.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: 18990149
• MDR Text Key: 338775531
• Report Number: 8030229-2024-04202
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2021
• 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