NA RNS-9703-242Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00851725007122), received between Sep 10, 2019 and Feb 10, 2023 — classified as 2 deaths, 6 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2023Output Problem; Output Problem

  THE NURSE REPORTED THAT THERE WERE ISSUES WITH TWO PATIENT VITALS. SHE SAID THAT THE PATIENT VITALS WERE MISSING FOR BED N-319 STARTING AT 10:54AM-12:40PM AND THAT THEY NOTICED THAT DURING THAT TIME BED ED 226 WAS SENDING ITS VITALS OVER TO BED N-319 AS WELL AS SHOWED UP IN ED 226. THE PATIENTS' VITALS IN BED ED 226 BEGAN SHOWING UP ON TWO DIFFERENT BED ID IN THEIR EMR. SHE ALSO MENTIONED THAT THIS ONLY BEGAN HAPPENING AFTER NK EMPLOYEES CAME IN TO UPDATE THE SOFTWARE FOR THE SERVER UPGRADE. THIS TIME FRAME WAS WHEN THE LAST MESSAGE WAS SEEN. THEY CHECKED THE SERVER AND DID NOT SEE ANY DUPLICATE BED IDS OR IPS. ON 319, THE ER PATIENT'S NAME AND ROOM NUMBER WAS DISPLAYED WITH 226'S (ER PT) VITAL SIGNS. ON 226, THE MONITOR DISPLAYED 226 NAME AND VITALS; BUT IN PARAGON (EMR) 226 VITALS SHOWED WITH A TEMP. THE ONLY PATIENT THAT HAD A TEMP PROBE IN USE (BETWEEN THESE 2 PATIENTS) WAS 319, SO THE TEMP VALUE THAT WAS COMING INTO PARAGON (EMR) ON 226 WAS FROM 319. THEY SAW THIS OCCURRING ON THE REMOTE NETWORK STATION (RNS). THEY DO NOT KNOW IF THIS WAS HAPPENING AT THE CENTRAL NURSE'S STATION (CNS) AS THEY DID NOT CHECK AT THE TIME. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16359061 ↗
• MalfunctionOct 29, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THEIR REMOTE NETWORK STATION (RNS) AND CENTRAL NETWORK STATION (CNS) ARE DISPLAYING INTERMITTENT SIGNAL LOSS FOR ALL MONITORED TELE BEDS. THE CUSTOMER SAID THAT THIS ISSUE USUALLY STARTS WITH A SINGLE TILE SHOWING SIGNAL LOSS AFTER WHICH ALL TILES START SHOWING THE SAME. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12723763 ↗
• MalfunctionOct 29, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THE REMOTE NETWORK STATION (RNS) AND CENTRAL NURSE'S STATION (CNS) WERE DISPLAYING INTERMITTENT SIGNAL LOSS FOR ALL MONITORED TELEMETRY TRANSMITTERS. THE CUSTOMER SAID THAT THIS ISSUE USUALLY STARTED WITH A SINGLE TILE SHOWING SIGNAL LOSS AFTER WHICH ALL TILES STARTED SHOWING THE SAME. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12723640 ↗
• DeathSep 7, 2021Protective Measures Problem; Protective Measures Problem

  THE CUSTOMER REPORTED THAT UPON REVIEWING A PATIENTS DATA WHO HAS JUST RECENTLY PASSED AWAY THEY DETERMINED THAT THE INCORRECT TIME WAS NOTED ON ALL OF THE INFORMATION WHEN VIEWED FROM THE REMOTE NETWORK STATION (RNS). THEY ALSO STATED THAT THEY WERE ABLE TO PHYSICALLY VIEW THE EVENT OF WHEN THE PATIENT PASSED AWAY ON THIS RNS, DESPITE IT HAPPENING EARLIER IN THE DAY. THE EVENT DID ALARM ON THE BEDSIDE MONITOR (BSM) AND THE DEPARTMENTS MAIN CENTRAL NURSE'S STATION (CNS). THE RNS ALSO ALARMED, BUT DUE TO IT BEING ON THE INCORRECT TIME, THE ALARM WAS DELAYED. THE CUSTOMER CONFIRMED THAT THE PATIENT DEATH WAS ANTICIPATED AND NOT DUE TO THE RNS MALFUNCTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12434003 ↗
• DeathSep 7, 2021Delayed Alarm; Use of Device Problem; Protective Measures Problem; Delayed Alarm; Use of Device Problem; Protective Measures Problem

  THE CUSTOMER REPORTED THAT UPON REVIEWING A PATIENT'S DATA WHO HAD JUST PASSED AWAY, THEY DETERMINED THAT THE INCORRECT TIME WAS NOTED ON ALL THE INFORMATION WHEN VIEWED FROM THE REMOTE NETWORK STATION (RNS). THEY WERE ABLE TO PHYSICALLY VIEW THE DEATH EVENT AT THIS RNS, BUT THE EVENT DID ALARM ON THE BEDSIDE MONITOR (BSM) AND THE DEPARTMENT'S MAIN CENTRAL NURSE'S STATION (CNS). THE RNS ALSO ALARMED, BUT AS IT WAS ON THE INCORRECT TIME, THE ALARM WAS DELAYED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12433999 ↗
• MalfunctionSep 10, 2019Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT A MEMORY ERROR CONSTANTLY POPPED UP ON THE REMOTE NETWORK SYSTEM (RNS) SCREEN. INITIALLY IT WAS REPORTED THAT WHEN OK WAS SELECTED, THE DEVICE WOULD SHUT DOWN AND RESTART BY ITSELF. LATER, IT WAS REPORTED THAT THE ERROR MESSAGE APPEARED IN THE MIDDLE OF THE SCREEN, A BLACK BOX MAYBE 3 X 4 INCHES. PRESSING OK OR IN THAT SCREEN AREA HAD NO AFFECT AND THE UNIT WOULD HAVE TO BE MANUALLY SHUT DOWN FOR IT TO GO AWAY. THE RNS WAS MONITORING PATIENTS AND THERE WAS NO 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 8984421 ↗
• MalfunctionSep 10, 2019Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT A MEMORY ERROR CONSTANTLY POPPED UP ON THE REMOTE NETWORK SYSTEM (RNS) SCREEN. INITIALLY IT WAS REPORTED THAT WHEN OK WAS SELECTED, THE DEVICE WOULD SHUT DOWN AND RESTART BY ITSELF. LATER, IT WAS REPORTED THAT THE ERROR MESSAGE APPEARED IN THE MIDDLE OF THE SCREEN, A BLACK BOX MAYBE 3 X 4 INCHES. PRESSING OK OR IN THAT SCREEN AREA HAD NO AFFECT AND THE UNIT WOULD HAVE TO BE MANUALLY SHUT DOWN FOR IT TO GO AWAY. THE RNS WAS MONITORING PATIENTS AND THERE WAS NO 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 8984415 ↗
• MalfunctionSep 10, 2019Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT A MEMORY ERROR CONSTANTLY POPPED UP ON THE REMOTE NETWORK SYSTEM (RNS) SCREEN. INITIALLY IT WAS REPORTED THAT WHEN OK WAS SELECTED, THE DEVICE WOULD SHUT DOWN AND RESTART BY ITSELF. LATER, IT WAS REPORTED THAT THE ERROR MESSAGE APPEARED IN THE MIDDLE OF THE SCREEN, A BLACK BOX MAYBE 3 X 4 INCHES. PRESSING OK OR IN THAT SCREEN AREA HAD NO AFFECT AND THE UNIT WOULD HAVE TO BE MANUALLY SHUT DOWN FOR IT TO GO AWAY. THE RNS WAS MONITORING PATIENTS AND THERE WAS NO 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 8984413 ↗