MAUDE Adverse Event Report: NIHON KOHDEN DIGITAL HEALTH SOLUTIONS CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION

Model Number EDNS-9001

Device Problems Power Problem (3010); Unintended Application Program Shut Down (4032)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2020

Event Type  malfunction  

Manufacturer Narrative

The customer stated that the prefense monitoring system went down while monitoring patients and the serial number provided for that unit was incorrect but insists that is the correct number.This is the unit that is being reported as the issue happened while in patient use.They were also trying to replace that failed unit with another prefense and are getting an error upon boot up of since windows was first activated on the computer the hardware on this computer has changed significantly, due to these changes, windows must be re-active within 3 days, to avoid being denied access please ask your computer admin to reactive windows on this computer.The ok button is pressed and the message disappeared and the unit began to function.Customer was able to monitor patients.Nihon kohden technical support informed the customer that windows cannot be reactivated and the hdd was most likely corrupted and device is at end of life and cannot be repaired.2nd unit was not is patient use yet when this the error message appeared.Prefense is used to monitor telemetry transmitters.No patient harm 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.Additional device information: concomitant medical device: the telemetry transmitters were being used in conjunction with the prefense but no model or serial numbers were provided.

Event Description

The customer stated that the prefense monitoring system went down while monitoring patients and the serial number provided for that unit was incorrect but insists that that is the correct number.This is the unit that is being reported as the issue happened while in patient use.They were also trying to replace that failed unit with another prefense and are getting an error upon boot up of since windows was first activated on the computer the hardware on this computer has changed significantly, due to these changes, windows must be re-active within 3 days, to avoid being denied access please ask your computer admin to reactive windows on this computer.The ok button is pressed and the message disappeared and the unit began to function.Customer was able to monitor patients.Nihon kohden technical support informed the customer that windows cannot be reactivated and the hdd was most likely corrupted and device is at end of life and cannot be repaired.2nd unit was not is patient use yet when this the error message appeared.Prefense is used to monitor telemetry transmitters.No patient harm reported.

Event Description

The customer reported that the prefense monitoring system went down while monitoring patients.They tried swapping the hard disc drives (hdds) from another device.Upon reboot, they received a windows error message.No patient harm reported.

Manufacturer Narrative

Details of complaint: the customer reported that the prefense monitoring system went down while monitoring patients.They tried swapping the hard disc drives (hdds) from another device.Upon reboot, they received a windows error message.No patient harm or injury was reported.Investigation summary: on a follow up with the customer, nihon kohden technical support (nk ts) informed the customer that windows could not be reactivated, and it is likely the hdds had been corrupted.This windows error message is normally received when the hardware has been changed and it prompts the user to reactivate windows.The customer was no longer able to reactivate windows, due to the likely corruption of the hdds.The device is already in end of life and there are no longer parts to repair the device.Based on the available information, a definitive root cause could not be identified.

• Brand Name: CENTRAL MONITORING SYSTEM
• Type of Device: CENTRAL MONITORING STATION
• Manufacturer (Section D): NIHON KOHDEN DIGITAL HEALTH SOLUTIONS; 14 bunsen; attn: shama mooman; irvine CA 92618
• Manufacturer (Section G): NIHON KOHDEN DIGITAL HEALTH SOLUTIONS; 14 bunsen; attn: shama mooman; irvine CA 92618
• Manufacturer Contact: shama mooman ; 14 bunsen; irvine, CA 92618 ; 9492687488
• MDR Report Key: 10039441
• MDR Text Key: 240429556
• Report Number: 2032233-2020-00254
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 00851725007023
• UDI-Public: 00851725007023
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102106
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EDNS-9001
• Device Catalogue Number: EDNS-9001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: TELEMETRY TRANSMITTERS; TELEMETRY TRANSMITTERS