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

Model Number CNS-6201A

Device Problem Connection Problem (2900)

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

Event Date 04/07/2022

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) rebooted on its own and when it came back up, one of the patient tiles was glitched.The bme reported that they were admitting the patient on to the tile and that is when the cns rebooted on its' own but all of the buttons are blank.No patient harm was reported.Nihon kohden technician attempted to troubleshoot the issue with the bme, but the issue persisted.Nk technician advised the bme that the cns needs to be sent into nihon kohden for repair.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) rebooted on its own and when it came back up, one of the patient tiles was glitched.The bme reported that they were admitting the patient on to the tile and that is when the cns rebooted on its' own but all of the buttons are blank.No patient harm was reported.Nihon kohden technician attempted to troubleshoot the issue with the bme, but the issue persisted.Nk technician advised the bme that the cns needs to be sent into nihon kohden for repair.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) rebooted on its own and when it came back up, one of the patient tiles was glitched.The bme reported that they were admitting the patient on to the tile and that is when the cns rebooted on its' own but all of the buttons are blank.No patient harm was reported.Nihon kohden technician attempted to troubleshoot the issue with the bme, but the issue persisted.Nk technician advised the bme that the cns needs to be sent into nihon kohden for repair.Investigation summary: the customer reported later that the issue was no longer occurring and was resolved but did not provide information regarding the resolution.It was suggested that the cause of the tile glitching was likely due to the software corruption on the cns.The cns was installed at the customer's facility in (b)(6) 2013 and is running version 02-10 which is an old version, likely root cause would be software corruption, using old software, and wear and tear.No additional issues were reported for this device, this appears to be an isolated event.A corrective and or preventative action is not warranted.Attempt #1: 04/25/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 04/26/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 04/29/2021 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) rebooted on its own and when it came back up, one of the patient tiles was glitched.The bme reported that they were admitting the patient on to the tile and that is when the cns rebooted on its' own but all of the buttons are blank.No patient harm was reported.Nihon kohden technician attempted to troubleshoot the issue with the bme, but the issue persisted.Nk technician advised the bme that the cns needs to be sent into nihon kohden for repair.

• 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: 14256760
• MDR Text Key: 290460095
• Report Number: 8030229-2022-02813
• 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: 07/19/2022

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: 04/07/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2012
• 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