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

Model Number CNS-6201A

Device Problems Operating System Becomes Nonfunctional (2996); Output Problem (3005)

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

Event Date 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported the central nurses station (cns) started boot looping.Technical support (ts) walked them through the hdd troubleshooting steps for both drives, but the issue persisted.The unit would boot into bios, and then, as soon as it is about to load windows, it shuts down and reboots itself without any error messages.The bme said the cns had been in use for two months, and the issue had just started.Before the boot looping, the bme noted there was an issue where the patient tiles would turn completely blank without any comm-loss errors.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.Attempt # 1: (b)(6)2023 emailed the bme for all items under the no information list.No reply was received.Attempt # 2: (b)(6)2024 emailed the bme for all items under the no information list.No reply was received.Attempt # 3: (b)(6)2024 emailed the bme for all items under the no information list.The bme replied that none of the requested information could be provided.

Event Description

The biomedical engineer (bme) reported the central nurses station (cns) started boot looping.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported the central nurses station (cns) started boot looping.Technical support (ts) walked them through the hdd troubleshooting steps for both drives, but the issue persisted.No patient harm was reported.Investigation summary: the reported device was sent in for evaluation and received by nk on 01/03/2024.During the evaluation, the reported problem of the cns "pu-681ra-l, (b)(6) boot looping" was duplicated on 04/24/2024.Upon startup, the cns showed a "no operation system found" error message.The hdds were re-imaged with the cns software, and the device then booted up normally.The cause of both the boot looping and blank tile issues was corruption of the operating system (os).Os corruption can occur through user error in file management, ungraceful shutdowns from the power supply, or by site power outages and surges.Review of the complaint device's serial number does not show recurrence or other similar complaints.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 12/29/2023 emailed the bme for all items under the no information list.No reply was received.Attempt # 2: 01/08/2024 emailed the bme for all items under the no information list.No reply was received.Attempt # 3: 01/15/2024 emailed the bme for all items under the no information list.The bme replied that none of the requested information could be provided.

Event Description

The biomedical engineer (bme) reported the central nurses station (cns) started boot looping.No patient harm was reported.

• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18531187
• MDR Text Key: 333499677
• Report Number: 8030229-2024-04041
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2018
• 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