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

Model Number CNS-6801A

Device Problem Computer Software Problem (1112)

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

The nurse reported that the central nurse's station (cns) shut down spontaneously and read system thread exception not handled.The hospital's bme re-booted the unit, and the cns came back up with a blue screen with the message "your computer ran into a problem and needs to be restarted".The bme had swapped the hard disc drives (hdds) in both ports 1 and 2 and confirmed that the hard disc drives (hdds) were corrupted.Technical support will send a replacement hard disc drive (hdds) under warranty.No patient harm was reported.

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) shut down spontaneously and read system thread exception not handled.The hospital's bme re-booted the unit, and the cns came back up with a blue screen with the message "your computer ran into a problem and needs to be restarted".The bme had swapped the hard disc drives (hdds) in both ports 1 and 2 and confirmed that the hard disc drives (hdds) were corrupted.Technical support will send a replacement hard disc drive (hdds) under warranty.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 field contains no information (ni), since the customer could not provide it d10 suspect medical device.Attempt # 1: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received, and the nurse provided patient demographic information.

Event Description

The nurse reported that the central nurse's station (cns) shut down spontaneously and read system thread exception not handled.The hospital's bme re-booted the unit, and the cns came back up with a blue screen with the message "your computer ran into a problem and needs to be restarted".The bme had swapped the hard disc drives (hdds) in both ports 1 and 2 and confirmed that the hard disc drives (hdds) were corrupted.Technical support will send a replacement hard disc drive (hdds) under warranty.No patient harm was reported.

Manufacturer Narrative

Incident summary: the nurse director reported that the cns shut down spontaneously.It had a message that read "system thread exception not handled" while monitoring patients.The nurse re-booted the unit, and the cns came back up and was functioning fine and the error message went away.Biomed called back the next morning stating that the cns was now showing a blue screen with the message "your computer ran into a problem and needs to be restarted".The biomed took the hdd out of port 2 and put in the other hdd into port 1 that was successful in booting up the computer.This confirmed that the hard disc drive (hdd) in port 2 was corrupted and will need to be replaced.Investigation summary: evaluation of the returned device was not able to confirm that the hard drive was corrupted.The customer had only returned the device with one hdd.Evaluation was able to confirm that the motherboard had failed which may have also contributed to the cns crashing.A failing motherboard indicates hardware failure.The unit was installed in 10/2021.Hardware failure could come as a result of physical, fluid, heat, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Fluid intrusion would result in electrical damage to internal components as well as possible corrosion.Heat damage could occur due to improper maintenance or placement.Electrical damage could occur during a power outage or power surge.Wear and tear of the component may have also contributed to failure.A serial number review of the reported device does not reveal additional related complaints.Complaint history review of the customer's account does not reveal similar complaints for the reported device.The following field contains no information (ni), since the customer could not provide it.D10 suspect medical device attempt # 1: 01/12/2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received, and the nurse provided patient demographic information.H11 additional manufacturer narrative, incident summary and investigation summary.

• 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: 18514998
• MDR Text Key: 333504103
• Report Number: 8030229-2024-04003
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White