N/A RNS-6803-7450Recalls & reported problems
Nihon Kohden Digital Health Solutions, LLC · Remote Network Station with Dell OptiPlex 24” All-In-One Computer · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00851725007153), received between Oct 29, 2019 and Oct 8, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Protective Measures Problem” (5 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 16, 2026.
Most reported problems
Device problems
- Protective Measures Problem5
- Device Alarm System2
- No Audible Alarm2
- Communication or Transmission Problem1
- Wireless Communication Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2021Protective Measures Problem; Protective Measures Problem
THE CUSTOMER REPORTED THAT NO SOUND WAS COMING FROM THE REMOTE NETWORK STATION (RNS) EVEN THOUGH THE RNS WAS VISUALLY SHOWING THAT IT WAS ALARMING. NO HARM OR INJURY OCCURED DURING THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12600601 ↗MalfunctionOct 8, 2021Protective Measures Problem; Protective Measures Problem
THE CUSTOMER REPORTED THAT NO SOUNDS ARE COMING FROM THE REMOTE NETWORK STATION (RNS) EVEN THOUGH THE RNS WAS VISUALLY SHOWING THAT IT WAS ALARMING. NO FURTHER INFORMATION WAS PROVIDED EXCEPT THAT NO HARM OR INJURY OCCURED DURING THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12600560 ↗MalfunctionDec 4, 2019Protective Measures Problem; Protective Measures Problem
THE CUSTOMER REPORTED THAT THEIR REMOTE NETWORK SYSTEM (RNS) AUDIBLE ALARM IS NOT SOUNDING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9414074 ↗MalfunctionNov 12, 2019Communication or Transmission Problem; Wireless Communication Problem; Communication or Transmission Problem; Wireless Communication Problem
THE CUSTOMER REPORTED THAT THEIR WAR ROOM REMOTE NETWORK SYSTEM (RNS) WAS SHOWING COMMUNICATION LOSS ON A VARIETY OF TELEMETRY BEDS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9312749 ↗MalfunctionOct 31, 2019Device Alarm System; No Audible Alarm; Protective Measures Problem; Device Alarm System; No Audible Alarm; Protective Measures Problem
THE BIOMEDICAL ENGINEER REPORTED THAT THE REMOTE NETWORK SYSTEM (RNS), THE SECONDARY MONITORING SYSTEM, DID NOT PROVIDE AUDIO. THERE WAS NO SOUND FOR THE ALARMS, QRS SYNC SOUNDS, ETC. THE ISSUE WAS RESOLVED BY REBOOTING THE UNIT. CUSTOMER WAS UNWILLING TO GATHER LOGS. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 9263308 ↗MalfunctionOct 29, 2019Device Alarm System; No Audible Alarm; Protective Measures Problem; Device Alarm System; No Audible Alarm; Protective Measures Problem
THE CUSTOMER REPORTED THAT THE SPEAKERS FAILED ON THE REMOTE NETWORK SYSTEM (RNS), THE SECONDARY MONITORING SYSTEM. THEY SPONTANEOUSLY STOPPED WORKING AND WERE MAKING BUZZING AND HUMMING SOUNDS. THE UNIT WAS REBOOTED, BUT THE ISSUE PERSISTED. THE PRIMARY MONITORING SYSTEM, THE CENTRAL NURSE'S STATION (CNS) WAS FUNCTIONAL AND MONITORING THE SAME PATIENTS WHEN THE RNS FAILED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 9253153 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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