BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSURE PAD FOR DIRECT SUPPLY ATTENDANT RESIDENT MONITORS

    MDR report key: 2090492 · Received May 12, 2011

    Report

    Report Number
    2090492
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 12, 2011
    Manufacturer
    DIRECT SUPPLY EQUIPMENT
    Product Code
    KMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ALARM PAD FOR THE WHEELCHAIR FAILED TO ALARM WITHIN THE TWO SECOND PARAMETER. THIS WAS NOT AN ISOLATED OCCURRENCE - UPON MONITORING OF THIS SITUATION, SEVERAL ALARM PADS (3) WERE FOUND TO HAVE BETWEEN A 4-16 SECOND DELAY IN ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE PAD FOR DIRECT SUPPLY ATTENDANT RESIDENT MONITORS PRESSURE PAD KMI DIRECT SUPPLY EQUIPMENT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES