BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE PLACE

    MDR report key: 9967669 · Received April 16, 2020

    Report

    Report Number
    9967669
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Date of Event
    March 25, 2020
    Report Date
    April 13, 2020
    Manufacturer
    RF TECHNOLOGIES, INC
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    NEW RF TAGS WERE PURCHASED. SHORTLY AFTER ADDING THEM TO THE SYSTEM, THE SYSTEM STARTED RECEIVING "CHECK BAND" ALERTS ON A ROUTINE BASIS. THE RNS WOULD CHECK THE BANDS AND THEY APPEARED TO BE OK. AFTER REPOSITIONING THEM THE ALERTS COULD BE CLEARED, BUT WOULD ALARM AGAIN AT A LATER TIME. SOMETIMES CHANGING THE TAG WOULD RESOLVE THE ISSUE AND SOMETIMES IT DID NOT. BIOMED WAS CALLED AND THEY WERE GOING TO INVESTIGATE RF INTERFERENCE IN THE ROOM FROM OTHER DEVICES IN THE ROOM, BUT THE PROBLEM SEEMED TO FOLLOW THE TAG TO OTHER ROOMS. OF THE 16 NEW TAGS PURCHASED, ONLY 2 APPEARED TO BE HAVING ISSUES; BIOMED THINKS THE LOT MAY BE BAD. THE DECISION WAS MADE TO CALL IN THE VENDOR (RF TECHNOLOGIES, INC.) TO EVALUATE THE SYSTEM. RF TECHNOLOGIES SENT A SERVICE REP TO INVESTIGATE. HE DETERMINED THE TAGS ARE DEFECTIVE AND NEED TO BE RETURNED FOR EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431602 SAFE PLACE MONITOR, BED PATIENT KMI RF TECHNOLOGIES, INC 6450-6262-1C

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA