N/A RNS-6803-3464Recalls & reported problems
Nihon Kohden Digital Health Solutions, LLC · Remote Network Station with Dell Inspiron 24” All-In-One Computer · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851725007139), received between Jan 1, 2021 and Apr 26, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Protective Measures Problem” (2 reports).
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
- Protective Measures Problem2
- Communication or Transmission Problem1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE BIOMEDICAL ENGINEER (BME) REQUESTED HELP WITH HIS REMOTE NETWORK STATION (RNS) CALIPER MEASUREMENTS, NOTING DISCREPANCIES BETWEEN HEART RATE (HR) READINGS ON THE RNS AND CENTRAL NURSE'S STATION (CNS) FOR A SPECIFIC PATIENT. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21915656 ↗MalfunctionOct 19, 2021Protective Measures Problem; Protective Measures Problem
THE CUSTOMER REPORTED THAT THE REMOTE NETWORK STATION (RNS) WAS NOT ALARMING. WHEN THEY ATTEMPTED TO REBOOT THE UNIT, IT GOT STUCK IN A BOOT LOOP. NO HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12662124 ↗MalfunctionOct 19, 2021Protective Measures Problem; Protective Measures Problem
THE CUSTOMER REPORTED THAT THEIR REMOTE NETWORK STATION (RNS) IS NOT ALARMING. THEY ALSO REPORTED THAT WHEN THEY ATTEMPTED TO REBOOT THE UNIT IT GOT STUCK IN A BOOT LOOP. NO HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12662123 ↗MalfunctionJan 1, 2021Communication or Transmission Problem; Communication or Transmission Problem
THE CUSTOMER REPORTED THAT SOME OF THEIR BEDS ARE DISAPPEARING FROM THE ALL BEDS SCREEN ON 2 OF THEIR REMOTE NETWORK SYSTEM (RNS) THAT ARE CONNECTED TO THE SAME, NEWLY INSTALLED, CRC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11103561 ↗
Other MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) devices
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- NA PU-621RNihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)17 deaths1,666 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls8 deaths1,217 reports
- NA PU-681RANihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)22 deaths1,493 reports
- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
- Patient Information Center iXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)83 deaths814 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
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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