BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURNCAIR LR SYSTEM

    MDR report key: 7448096 · Received April 20, 2018

    Report

    Report Number
    3009402404-2018-00022
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    April 16, 2018
    Report Date
    April 20, 2018
    Manufacturer
    KAP MEDICAL
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, PATIENT FELL OUT OF BED AND SUSTAINED BUMPS/BRUISES. THE PATIENT WAS CHECKED BY STAFF DOCTOR AND RECEIVED X-RAY/CT SCAN. BOTH SCANS WERE NEGATIVE. (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 HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289780 TURNCAIR LR SYSTEM PATIENT AIR MATTRESS FNM KAP MEDICAL TCLR-3680-M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization