BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECA 286

    MDR report key: 7850151 · Received September 6, 2018

    Report

    Report Number
    7850151
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    August 20, 2018
    Report Date
    August 27, 2018
    Manufacturer
    SECA CORP.
    Product Code
    FRI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHEN PERFORMING A DEVICE CALIBRATION/FUNCTIONALITY CHECK ON THE SCALE, THE BIOMED ENGINEER DISCOVERED AN INCREASE OF 100 CM ON THE ACTUAL CALIBRATED ROD HEIGHT READING WHICH SHOULD BE AT 81.5 CM. UNIT CALIBRATION CHECK IS PERFORMED WITH A MANUFACTURER SUPPLIED CALIBRATION ROD THAT MEASURES 81.5 CM WHICH SHOULD BE READ BY THE SCALE DURING THE FUNCTIONALITY CHECK PROCESS. THE SECA 286 SCALE COMES WITH THE OPTION OF THREE PAIRS OF ULTRASONIC SENSORS LOCATED AT THE TOP OF THE UNIT THAT RECORDS PATIENT'S HEIGHT IN MILLISECONDS WHICH ARE THEN ELECTRONICALLY FED TO THE ELECTRONIC MEDICAL RECORD (EMR). IF ANY OTHER SONAR EMITTING DEVICES, FOR EXAMPLE, A SONAR EQUIPPED LIGHT SWITCH FIXTURE, COMMONLY USED TO CHECK FOR ROOM OCCUPANCY TO TURN AND KEEP LIGHTS ON OR OFF ARE IN THE VICINITY OF THE SCALE, IT COULD CAUSE INCORRECT MEASUREMENT ON THE HEIGHT READING, WITHOUT ANY WARNINGS COMING FROM THE SCALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692866 SECA 286 SCALE, STAND-ON, PATIENT FRI SECA CORP. 286

    Patients

    Seq Age Sex Outcome Treatment
    1