BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAFLOAT LAL SYSTEM

    MDR report key: 7790290 · Received August 16, 2018

    Report

    Report Number
    3009402404-2018-00052
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    July 23, 2018
    Report Date
    August 16, 2018
    Manufacturer
    FXI
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "BOLSTERS WEREN'T INFLATED. PATIENT FELL OUT OF BED." THE PATIENT DID NOT SUSTAIN ANY INJURIES. NUMEROUS REQUESTS TO THIS FACILITY HAVE BEEN MADE TO RECEIVE ADDITIONAL INFORMATION AND DETAILS RELATED TO THIS ALLEGED INCIDENT REPORT WITH NO RESPONSE FROM THE FACILITY. (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE MATTRESS AND CONTROL UNIT RETURNED TO JOERNS FOR INVESTIGATION. AS OF THIS WRITING, THE MATTRESS AND CONTROL UNIT HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630295 DERMAFLOAT LAL SYSTEM PATIENT AIR MATTRESS FNM FXI DFLAL-3680-M

    Patients

    Seq Age Sex Outcome Treatment
    1