BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 17613909 · Received August 24, 2023

    Report

    Report Number
    2027454-2023-00067
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 24, 2023
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761995079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HILLROM TECHNICIAN FOUND THE CODE BLUE WAS NOT CONFIGURED FOR SOME ROOMS. THE VOALTE® PATIENT SAFETY APPLICATION IS INTENDED TO COLLECT MEDICAL DEVICE DATA, INCLUDING THERAPY SURFACE AND PATIENT PARAMETERS, TO DOCUMENT ACTIVITIES AND TO ALERT CAREGIVERS AND OTHER PERSONNEL BASED ON CAREGIVER SPECIFIED CRITERIA AND SYSTEM EVENTS. THESE ALERTS AND NOTIFICATIONS WILL BE SENT VIA NETWORK APPLICATION, NURSE COMMUNICATION (OPTIONAL), AND WIRELESS COMMUNICATION DEVICES WITHIN THE HEALTHCARE ENVIRONMENT. THE APPLICATION WILL PROVIDE REPORTS ON THE DATA COLLECTED AND ALERTS GENERATED. THE APPLICATION WILL ALSO PROVIDE DEFAULT VOALTE® PATIENT SAFETY PROTOCOLS WHICH ALLOW CAREGIVERS TO CUSTOMIZE VOALTE®PATIENT SAFETY PROTOCOLS, WITHIN THE APPLICATION, BASED ON THEIR RISK ASSESSMENT OF THE PATIENT. PATIENT SAFETY WILL MONITOR THE VOALTE® PATIENT SAFETY PROTOCOLS SET BY THE CAREGIVER AND THE ASSOCIATED DATA POINTS AND ALERT CAREGIVERS WHEN THE PROTOCOL SETTINGS ARE VIOLATED OR REQUIRE ATTENTION. THE APPLICATION INCLUDES WORKFLOW CAPABILITIES THAT ALLOW TURNING OFF BED EXIT AND SUPPRESSION (OR SILENCING) OF ASSOCIATED ALERTS AS WELL AS AUTOMATIC ENABLING OF BED EXIT AND ASSOCIATED ALERTS. THE HRC TECHNICIAN CORRECTED THE ISSUE IN ECT FOR THE CUSTOMER TO RESOLVE THE ISSUE. 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.

    Description of Event or Problem · 0

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE CODE BLUE IS NOT AUDIBLE AT THE OPERATING ROOMS, 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
    1038177 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 00887761995079

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown