BEUDAMED
    FDA Adverse Event Other Summary report: N

    RF TECHNOLOGIES

    MDR report key: 2362784 · Received December 7, 2011

    Report

    Report Number
    MW5023325
    Event Type
    Other
    Date Received
    December 7, 2011
    Date of Event
    November 23, 2011
    Report Date
    November 23, 2011
    Manufacturer
    RF TECHNOLOGIES
    Product Code
    KMI
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SAFE PLACE TECHNICAL SERVICES REQUESTED. NEEDED ASSISTANCE WITH INNUMERABLE ALARMS OF INFANT SECURITY SYSTEM NOT ABLE TO BE MANAGED ON LOCAL LEVEL. FREQUENT ALARMING OF "CHECK BAND", "DEVICE FAULT" AND "CLIENT MISSING" OVER AND OVER AND OVER DURING THE COURSE OF SEVERAL DAYS. LEARNED TODAY THE (B)(6) 2011 REQUESTED TECH PROMISED WOULD NOT BE AVAILABLE TILL (B)(6) 2011. PT, VISITORS AND STAFF HAVE TO DEAL WITH FREQUENT AND SOMETIMES CONSTANT ALARMS, CAUSING IRRITABILITY AND ALARM FATIGUE - PLUS NOT HAVING A SECURE ENVIRONMENT FOR THE BABIES. THIS ONE OF MONTHS OF ISSUES WITH THIS SYSTEM. EXP DATE: SENSORS - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF TECHNOLOGIES SAFE PLACE INFANT SECURITY SYSTEM KMI RF TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1