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

Model Number CNS-6801A

Device Problems Application Program Problem (2880); Unintended Application Program Shut Down (4032)

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

Event Date 01/17/2024

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was boot looping and would not load into the application.They rebooted the unit and also shut it down.However, the issue persists.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) was boot looping and would not load into the application.They rebooted the unit and also shut it down.However, the issue persists.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 attempts to obtain information were made, but the information was not provided.A2 - a6 b6 - b7 d10 concomitant medical device attempt #1 01/18/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 01/24/2024 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient information as requested.They provided some of the additional device information.Bedside monitor(s) model: bsm-6501a sn: ni device manufacturer date: ni unique identifier (udi) #: (b)(4) returned to nihon kohden: not returned.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) was boot looping and would not load into the cns application.They rebooted the cns and shut it down, which did not resolve the issue.No patient harm was reported.Investigation summary: the cns, (pu-681ra, sn: (b)(6), was returned, cleaned, decontaminated, and evaluated.During the evaluation nihon kohden repair center (nk rc) was able to duplicate the issue, as the cns was boot looping, indicating there was a software issue and an issue with the hard disk drive (hdd).Nk rc reimaged the hdd and installed the cns software (version 02-20), completed calibration / initialization, and checked the network functions, which all passed.The device was then subjected to extended testing and passed all (post repair) inspections and testing, meeting specifications in all areas.The device will be dispositioned to stock as we have already shipped the customer a new exchange cns, (pu, 681ra, sn: (b)(6), to resolve the issue.Nk confirmed the reported issue was attributed to an issue with the software and the hdd, likely due to a power issue, such as an unexpected shutdown, caused by an ungraceful exit, power surge / outage, causing corruption of the hdd, and leading to the software and hdd issue.During a review of the device history, this was found to be an isolated issue.There is no indication of improper / inadequate device design, as there has been no significant trend for this issue.Only one (1) reported issue has been reported by the facility for this device, occurring in the past three (3) years.As such, no further corrective action is needed.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the cns: model: bsm-6501a sn: (b)(6) device manufacturer date: ni unique identifier (b)(4) returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was boot looping and would not load into the cns application.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: 18700560
• MDR Text Key: 336430353
• Report Number: 8030229-2024-04101
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2023
• 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: BSM; BSM-6501A SN (B)(6)