NK-HealthProtect Wireless Surge Solution A-WSS-002-ZARecalls & reported problems
Nihon Kohden America, Inc. · Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patients with pop-up central monitoring · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841983104336), received between Jan 31, 2025 and Jan 31, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Connection Problem1
- Patient Data Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2025Connection Problem; Patient Data Problem; Connection Problem; Patient Data Problem
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21289161 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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