NaviCare® Nurse Call Systems 3.6Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887761001541), received between Nov 30, 2017 and Nov 7, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (9 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 14, 2021Class IITerminated

   An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.

   Z-0402-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Device Alarm System; Device Alarm System

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CODE CALL WAS NOT ALERTING . THERE WAS NO PATIENT/USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498684 ↗
• MalfunctionMar 14, 2025Device Alarm System; Device Alarm System

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CODE BLUE WAS NOT ANNUNCIATING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612105 ↗
• MalfunctionJul 24, 2024Device Alarm System; Device Alarm System

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CODE BLUE FAILED. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822649 ↗
• MalfunctionJun 1, 2024Device Alarm System; Device Alarm System

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE BED EXIT WAS NOT ANNUNCIATING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441809 ↗
• MalfunctionDec 22, 2023Device Alarm System; Device Alarm System

  HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE CODE CALLS WERE NOT ANNUNCIATING IN THE CORRECT LOCATION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387294 ↗
• MalfunctionSep 27, 2023Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED THE BED ALARMS WERE NOT ROUTING TO THE NURSE'S STATION. A PATIENT FALL OCCURRED BUT THERE WAS NO INJURY TO THE PATIENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826431 ↗
• MalfunctionJul 20, 2023Activation Problem; Activation Problem

  THE CUSTOMER REPORTED THE CODE BLUE CORD ON THE NAVICARE NURSE CALL SYSTEM WAS PULLED BUT THE CODE CALL DID NOT ANNUNCIATE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17364634 ↗
• MalfunctionMay 15, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE CODE BLUE CALL FOR 4 SOUTH ROOMS 425 AND 424 DID NOT ROUTE, VIA THE NURSE CALL SYSTEM, TO THE SWITCHBOARD OPERATOR LOCATION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT IMPACT OR INJURY ASSOCIATED WITH THIS EVENT, AND THE ALERT ROUTED AND ANNUNCIATED PROPERLY IN THE ASSOCIATED ROOMS AND ON THE ASSOCIATED UNIT. IT IS NOTED THAT THE ASSOCIATED ROOMS ARE "NEW INSTALLATION THAT OPENED RECENTLY." THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929425 ↗
• MalfunctionApr 5, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED BY THE CUSTOMER THAT A CODE BLUE DOES NOTHING, DOES NOT SOUND, LIGHTS, SHOWS IN THE NURSE CALL GRAPHIC ROOM STATION WITH 10¿ SCREEN GRS 10. THERE WAS NO PATIENT IMPACT REPORTED AS A RESULT OF PRODUCT PERFORMANCE. THIS COMPLAINT WAS CAPTURED UNDER HILLROM REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682011 ↗
• InjuryMar 31, 2023Device Alarm System; Device Alarm System

  THE CUSTOMER CONTACTED HILLROM TO REPORT A FALL EVENT AND REQUESTED A NURSE CALL REPORT. THE CUSTOMER REPORTED THAT A PATIENT FELL THREE WEEKS PRIOR TO NOTIFYING HILLROM, AND THAT AT THE TIME OF THE EVENT, THE BED EXIT CALL DID NOT THE ANNUNCIATE AT THE CONSOLE OR AT THE DOME LIGHT CAUSING A DELAY IN RESPONSE. THE PATIENT SUSTAINED AN UNSPECIFIED FRACTURE WHICH REQUIRED SURGICAL INTERVENTION. IT IS NOTED THAT THE PATIENT HAS RECOVERED AND IS CURRENTLY IN ONGOING REHAB. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 16655232 ↗
• MalfunctionFeb 27, 2023No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT CODE BLUE CALLS WERE NOT ANNUNCIATING AT THE PBX OPERATOR FOR ROOMS ICU 01 AND ICU 03 ON THE 2ND FLOOR; HOWEVER, THE CALLS WERE ANNUNCIATING LOCALLY. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442118 ↗
• MalfunctionNov 30, 2017Computer Software Problem; Computer Software Problem

  HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE CODE BLUE LEVER WAS PULLED BUT THAT THE CALL WAS DELAYED IN RINGING AT THE PRIMARY NURSE STATION.

  Patient problems: No Information

  MAUDE report 7073275 ↗