BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 16859610 · Received May 3, 2023

    Report

    Report Number
    2027454-2023-00037
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    May 9, 2023
    Report Date
    April 9, 2023
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761985209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE VOALTE NURSE CALL SYSTEM PROVIDES VISUAL AND/OR AUDIBLE EVENT ALERT NOTIFICATION VIA DESIGNATED COMMUNICATION DEVICES. THE ROUTING OF AN ALERT TO SAID COMMUNICATION DEVICES (PRIMARY AND SECONDARY) IS CONFIGURED BASED ON CUSTOMER PREFERENCES. ALL CALLS ROUTE TO A PRIMARY MONITORING DEVICE (GRS-10 NURSE CONSOLE, CALLS CAN ALSO TO BE CONFIGURED TO ROUTE TO SECONDARY COMMUNICATION DEVICE LOCATIONS (PBX OPERATOR, WIRELESS PHONES, ETC). TROUBLESHOOTING ACTIVITIES PERFORMED BY HILLROM TECHNICIAN DETERMINED THAT THE ASSOCIATED UNIT/ROOMS NEEDED TO BE ADDED TO THE PBX MONITORING CONFIGURATION. THE CONFIGURATION WAS PROGRAMMED SO THAT THE ASSOCIATED PBX COULD MONITOR THE ASSOCIATED UNIT'S CODE BLUE CALLS. THE CUSTOMER CONFIRMED THE CONFIGURATION CHANGE WORKED AS INTENDED. NO FURTHER ASSISTANCE WAS REQUIRED BY THE CUSTOMER. IT IS NOTED THAT IT WAS THE CUSTOMER'S EXPECTATION THAT THE UNIT'S CODE BLUE CALLS WERE ALREADY BEING MONITORED BY PBX. IN THIS EVENT, THERE WAS NO INJURY OR IMPACT TO ANY PATIENTS, AS CONFIRMED BY THE CUSTOMER WHICH CONCLUDES A SERIOUS INJURY DID NOT OCCUR. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT THE CALL ROUTED APPROPRIATELY TO THE PRIMARY LOCATION OF THE DEVICE. THE ROOT CAUSE OF THE EVENT WAS THAT THE CONFIGURATION OF THE ASSOCIATED UNIT DID NOT INCLUDE MONITORING BY THE PBX LOCATION, WHICH WAS RESOLVED BY A CONFIGURATION CHANGE. ALTHOUGH THERE WAS NO INJURY, IF A CODE BLUE CALL NOT ROUTING TO THE PBX WERE TO RESULT IN A MISSED CODE CALL NOTIFICATION IT WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CODE BLUE CALLS FOR THE LABOR AND DELIVERY UNIT ROOMS (B)(6) DID NOT ROUTE, VIA THE VOALTE NURSE CALL SYSTEM, TO THE PBX OPERATOR LOCATION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT IMPACT OR INJURY ASSOCIATED WITH THIS EVENT, AND THE ALERT ROUTED PROPERLY TO THE ASSOCIATED UNIT. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196180 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 3.9 00887761985209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown