BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVICARE NURSE CALL

    MDR report key: 10494436 · Received September 4, 2020

    Report

    Report Number
    2027454-2020-00002
    Event Type
    Death
    Date Received
    September 4, 2020
    Date of Event
    August 7, 2020
    Report Date
    September 3, 2020
    Manufacturer
    HILL ROM
    Product Code
    ILQ
    UDI-DI
    00887761985209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    HILLROM INVESTIGATION FOUND NO PRODUCT ERROR AND THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED. A REVIEW OF THE LOG FILES INDICATE THE NURSE CALL SYSTEM WAS ALERTING CALLS FROM THE 3RD PARTY EQUIPMENT IN QUESTION PRIOR TO THE EVENT AND INDICATE A POTENTIAL ERROR WITH THE 3RD PARTY EQUIPMENT. THE LOGS INDICATE THE DAY PRIOR TO THE EVENT THE NURSE CALL SYSTEM HAD A EQUIPMENT DISCONNECT CALL FOR THE 3RD PARTY EQUIPMENT, WHICH WAS CANCELED IN THE ROOM. THE CONCLUSION IS THE EQUIPMENT WAS NOT RECONNECTED AFTER THIS CALL WAS CANCELED. HILLROM REQUESTED ACCESS TO THE 3RD PARTY EQUIPMENT, HOWEVER THE USER FACILITY HAS NOT PROVIDED ACCESS.

    Description of Event or Problem · 1

    HILLROM RECEIVED A REPORT FROM THE ACCOUNT THAT NO NURSE CALL WAS RECEIVED FROM A VENTILATOR CONNECTED TO THE NURSE CALL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961845 NAVICARE NURSE CALL NAVICARE NURSE CALL ILQ HILL ROM NNC 3.9.201 00887761985209

    Patients

    Seq Age Sex Outcome Treatment
    1 Death