NA RNS-9703-024Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00851725007016), received between Mar 15, 2016 and Sep 16, 2019 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission 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

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2019No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE REMOTE NETWORK STATION (RNS) HAD A BLANK DISPLAY AFTER A POWER OUTAGE. THE RNS WAS MONITORING PATIENTS AND IT WAS UNCLEAR WHETHER THERE WAS A CENTRAL NURSE'S STATION (CNS) IN USE AS A PRIMARY MONITORING SYSTEM WHEN THIS RNS FAILED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9073681 ↗
• MalfunctionMar 15, 2016Protective Measures Problem; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THE REMOTE NETWORK STATION (RNS OR REMOTE MONITORING SYSTEM) HAS VERY LOW VOLUME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501982 ↗
• MalfunctionMar 15, 2016Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT ALL THEIR RNS DEVICES WENT INTO COMMUNICATION LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501978 ↗
• MalfunctionMar 15, 2016Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT BOTH REMOTE NETWORK STATIONS (RNS OR REMOTE MONITORING SYSTEM) ARE EXPERIENCING COMMUNICATION LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501963 ↗
• MalfunctionMar 15, 2016Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE RNS HAD NO AUDIO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501951 ↗
• OtherMar 15, 2016No Audible Alarm; Protective Measures Problem; No Audible Alarm; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THE REMOTE NETWORK STATION (RNS OR REMOTE MONITORING SYSTEM) HAS LOW VOLUME ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501671 ↗
• MalfunctionMar 15, 2016No Audible Alarm; Protective Measures Problem; No Audible Alarm; Protective Measures Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY CANNOT HEAR THE AUDIO ALARMS FROM THE RNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501633 ↗
• MalfunctionMar 15, 2016Electrical /Electronic Property Problem; Failure to Power Up; Complete Loss of Power; Electrical /Electronic Property Problem; Failure to Power Up; Complete Loss of Power

  THE CUSTOMER REPORTED THAT THE RNS FAILED, AND WOULD NOT POWER ON. THE DEVICE SHUT DOWN DURING NORMAL OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501587 ↗
• MalfunctionMar 15, 2016Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT ALL OF THE RNS DEVICES WERE IN COMM LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501563 ↗
• MalfunctionMar 15, 2016Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THE RNS WENT INTO COMM LOSS ON ALL BEDSIDES FOR AN UNKNOWN AMOUNT OF TIME (OVER 10 MINUTES), AND THEN CAME OUT OF COMM LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501538 ↗
• MalfunctionMar 15, 2016Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT BOTH REMOTE NETWORK STATIONS (RNS OR REMOTE MONITORING SYSTEM) ARE EXPERIENCING COMMUNICATION LOSS. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501529 ↗
• MalfunctionMar 15, 2016Electrical /Electronic Property Problem; Intermittent Loss of Power; Electrical /Electronic Property Problem; Intermittent Loss of Power

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE RNS KEPT POWER CYCLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501508 ↗
• MalfunctionMar 15, 2016No Display/Image; Output Problem; No Display/Image; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE DISPLAY ON THE RNS WENT COMPLETELY BLANK, AND THEN INVERTED THE DISPLAY. THE RNS WOULD ALSO LOSE MOUSE CONTROL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501499 ↗
• MalfunctionMar 15, 2016No Display/Image; Output Problem; No Display/Image; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE DISPLAY ON THE RNS WENT COMPLETELY BLANK, AND THEN INVERTED THE DISPLAY. THE RNS WOULD ALSO LOSE MOUSE CONTROL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501491 ↗
• MalfunctionMar 15, 2016No Display/Image; Output Problem; No Display/Image; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE RNS IN 36 NORTH HAD A BLACK DISPLAY EVEN AFTER RESETTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5501401 ↗