BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE PLACE

    MDR report key: 14929597 · Received July 6, 2022

    Report

    Report Number
    14929597
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    April 22, 2022
    Report Date
    May 25, 2022
    Manufacturer
    RF TECHNOLOGIES, INC
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFANT SECURITY SYSTEM MANUFACTURED BY RF TECHNOLOGIES HAS HAD MULTIPLE INSTANCES OF FAILURE. BANDS HAVE EITHER ALARMED WHEN ON THE PATIENTS OR NOT ALARMED WHEN THEY HAVE BEEN CUT OFF THE PATIENT. VENDOR REPORTS THAT IT IS A KNOWN ISSUE WITH THE SOFT BANDS YET STILL MARKETED THIS PRODUCT AS FUNCTIONAL. AFTER REPORTING EVENTS TO VENDOR, IT WAS REPORTED THAT THESE TYPES OF MALFUNCTIONS WERE KNOWN TO OCCUR WITH THE SOFT BANDS SUPPLIED BY THE VENDOR AND THEY ARE LOOKING FOR A NEW SUPPLIER OF SOFT BANDS TO PROVIDE TO US. WE ARE NOW HAVING TO USE THE HARD/INFLEXIBLE BANDS THAT HAVE MORE OF A RISK OF CAUSING DISCOMFORT OR RISK OF PAIN TO THE INFANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481633 SAFE PLACE MONITOR, BED PATIENT KMI RF TECHNOLOGIES, INC ML722132

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown