MAUDE Adverse Event Report: NIHON KOHDEN DIGITAL HEALTH SOLUTIONS, INC. NK-HEALTHPROTECT WIRELESS SURGE SOLUTION; CENTRAL MONITORING STATION

Model Number	A-WSS-002-ZA
Medical Device Problem Codes	Connection Problem (2900); Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint summary: the biomedical engineer (bme) reported that the gz transmitters dropped from the wireless surge system (a-wss-002-za).Bme went to the device and reset everything on the wss and gz's then added them back to the wss.The hospital uses this wss with their own wlan network, not the hotspot the system comes with, and it is hooked up to a bigger monitor and mouse/keyboard.No patient harm was reported.Nihon kohden technical support/troubleshooting: nk technical support informed the bme that the issue with the gz's randomly dropping and having to be reset and adding them back are indicative of communication issues on their network.Bme also reported that the monitor screen was flickering and wanted to know why it was doing this.Nk technician told bme that the issue of the monitor screen flickering is also indicative of the laptop having to work harder than normal as the configurations are non-validated and atypical to how nihon kohden set these devices up.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: (b)(6)2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: (b)(6)2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: (b)(6)2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.
Event or Problem Description
The biomedical engineer (bme) reported that the gz transmitters dropped from the wireless surge system (a-wss-002-za).Bme went to the device and reset everything on the wss and gz's then added them back to the wss.The hospital uses this wss with their own wlan network, not the hotspot the system comes with, and it is hooked up to a bigger monitor and mouse/keyboard.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the gz transmitters dropped from the wireless surge system (a-wss-002-za).Bme went to the device and reset everything on the wss and gz's then added them back to the wss.The hospital uses this wss with their own wlan network, not the hotspot the system comes with, and it is hooked up to a bigger monitor and mouse/keyboard.No patient harm was reported.
Additional Manufacturer Narrative
Incident summary: on 01/03/2025, the biomed reported that their gz's were randomly dropping off the monitoring screen.The biomed was able to resolve the issue by resetting their prefense application (wss) (a/prefense-wss, serial number (b)(6)) and adding them back onto the wss.Additionally, the screens on the gzs were flickering but nk technical support advised the biomed this was due to the laptop having to work harder than normal.Investigation summary: the quality team followed up with the customer to ensure the issue was resolved and the customer stated that the issue was caused by their nursing staff making changes to the system when they should not have been.There was patient involvement when the issue occurred, but no report of patient harm, no injury, nor any adverse event, due to the reported issue.We were unable to confirm the reported issue.A definitive root cause cannot be determined, but based on the available information the most probable root cause was due to user error.The biomed informed nk that their nursing staff were making changes to the system when they should not have.The biomed stated they spoke with the staff to prevent any other changes.Device history: a serial number review of the reported device (a/prefense-wss, serial number (b)(6)) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.Additional information: b4: date of this report.G3: date received by manufacturer.G6: type of report.H2: if follow-up, what type? h6: adverse event problem codes.H11: additional manufacturer narrative.

• Brand Name: NK-HEALTHPROTECT WIRELESS SURGE SOLUTION
• Common Device Name: CENTRAL MONITORING STATION
• Manufacturer (Section D): NIHON KOHDEN DIGITAL HEALTH SOLUTIONS, INC.; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer (Section G): NIHON KOHDEN DIGITAL HEALTH SOLUTIONS, INC.; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 21289161
• Report Number: 8030229-2025-04663
• Device Sequence Number: 9530111
• Product Code: MHX
• UDI-Device Identifier: 00841983104336
• UDI-Public: (01)00841983104336
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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
• Operator of Device: Health Professional
• Device Model Number: A-WSS-002-ZA
• Device Catalogue Number: A-WSS-002-ZA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GZ TRANSMITTER; GZ TRANSMITTER
• Patient Sex: Unknown