BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVICARE NURSE CALL OR VOALTE

    MDR report key: 15301022 · Received August 25, 2022

    Report

    Report Number
    MW5111729
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    August 1, 2022
    Report Date
    August 23, 2022
    Manufacturer
    HILL-ROM, INC.
    Product Code
    ILQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HILL-ROM NURSE CALL MULTIPLE ROOM FAILURE. (B)(6) CLINICAL ENGINEERING PERFORMED FIRST-CALL TROUBLESHOOTING AND HARDWARE REPLACEMENTS IN TWO ROOMS IN GYNECOLOGIC ONCOLOGY AND ONE ROOM IN RADIATION ONCOLOGY. A TICKET WAS PLACED WITH HILL-ROM TO CONFIGURE THE NEW HARDWARE, HOWEVER, THEY DID NOT HAVE A TECHNICIAN AVAILABLE AT THAT TIME, AND AGREED TO LOG IN REMOTELY AND CONFIGURE THE EQUIPMENT BEFORE BUSINESS HOURS THE NEXT MORNING. THE NEXT DAY IT WAS DISCOVERED THAT HILL-ROM HAD COMPLETED NO WORK ON THIS ISSUE AND THE THREE ROOMS WERE LEFT WITH NO FUNCTIONING NURSE CALL SYSTEM--NO LIGHTS OR TONES. CLINICAL ENGINEERING ESCALATED THE NEXT MORNING, AND HILL-ROM AND AFTER SEVERAL HOURS, SUCCESSFULLY CONFIGURED THE HARDWARE AND RESTORED FUNCTIONALITY TO THE AFFECTED ROOMS. COMMUNICATION WAS POOR FROM HILL-ROM AND NO FOLLOW UP FROM HILL-ROM UNTIL WE CALLED AGAIN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344429 NAVICARE NURSE CALL OR VOALTE SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM, INC. NNC OR VOALTE NURSE CALL
    2344430 NAVICARE NURSE CALL OR VOALTE SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM, INC. NNC OR VOALTE NURSE CALL
    2344431 NAVICARE NURSE CALL OR VOALTE SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM, INC. NNC OR VOALTE NURSE CALL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown