BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE CALL

    MDR report key: 17671675 · Received September 1, 2023

    Report

    Report Number
    2027454-2023-00070
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 4, 2023
    Report Date
    October 25, 2023
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761985209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HILLROM TECHNICIAN FOUND NO ISSUES WITH THE DEVICE. THE NAVICARE® NURSE CALL¿ (NNC) SYSTEM IS A COMPREHENSIVE COMMUNICATION AND INFORMATION MANAGEMENT SYSTEM THAT HELPS CAREGIVERS PROVIDE THE BEST POSSIBLE CARE TO PATIENTS IN THE MOST EFFICIENT MANNER. THE SYSTEM FACILITATES COMMUNICATION WITHIN A NURSING UNIT. CAREGIVERS HAVE THE ABILITY TO QUICKLY LOCATE AND COMMUNICATE WITH A FELLOW STAFF MEMBER, AND PATIENTS CAN EASILY COMMUNICATE WITH CAREGIVERS, THE NURSING STATION, OR DIRECTLY TO THEIR PRIMARY CAREGIVER. THE HILLROM VOALTE NURSE CALL SYSTEM PROVIDES VISUAL AND/OR AUDIBLE EVENT ALERT NOTIFICATION VIA DESIGNATED COMMUNICATION DEVICES (NURSES CONSOLE, PATIENT ROOM DOME LIGHTS, MOBILE PHONES (IF APPLICABLE)). NOTIFICATION OF CALLS IS CONFIGURED WITH THE NAMING CONVENTION, AUDIO AND /OR VISUAL DISPLAYS BASED ON THE CUSTOMER PREFERENCE AT THE TIME OF INITIAL INTEGRATION. CONFIGURATION CHANGES MAY ALSO BE PERFORMED BY HILLROM TECHNICAL SUPPORT THEREAFTER UPON RECEIPT OF CUSTOMER REQUEST. ALTHOUGH THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT, IF THE REPORTED ISSUE WERE TO RECUR IT COULD LEAD TO INJURY OR DEATH. THEREFORE HILLROM IS REPORTING THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE CODE CALL WAS INCONSISTENT WHEN ALERTING TO MOBILE DEVICES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE CODE CALL WAS INCONSISTENT WHEN ALERTING TO MOBILE DEVICES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155306 NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 00887761985209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown