BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAFLOAT APM MATTRESS

    MDR report key: 7168241 · Received January 5, 2018

    Report

    Report Number
    3009402404-2018-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    December 8, 2017
    Report Date
    January 5, 2018
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND ANY RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "THE PATIENT SLID OFF OF THE SIDE OF THE BED ONTO THE FLOOR WHILE HOLDING ONTO THE RAIL OF THE BED. THERE WERE NO 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
    13265 DERMAFLOAT APM MATTRESS PATIENT AIR MATTRESS FNM JOERNS HEALTHCARE DFAPM-3680-M

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR