BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARECHAIR

    MDR report key: 9272612 · Received November 4, 2019

    Report

    Report Number
    3009402404-2019-00072
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 15, 2019
    Report Date
    November 4, 2019
    Manufacturer
    CAMTEC
    Product Code
    BYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, PATIENT FELL OUT OF THE CHAIR AS THEY WERE MOVING THE PATIENT. THE PATIENT SUSTAINED A SKIN TEAR TO THE ELBOW AND THE FACILITY IS PERFORMING X-RAYS IN-HOUSE. 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 CHAIR RETURNED TO JOERNS FOR INVESTIGATION. THE CHAIR WAS RECEIVED AT JOERNS (B)(4) ON 10/29/2019 AND THE INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065380 CARECHAIR PATIENT CHAIR WITH WHEELS BYN CAMTEC RCCC650B

    Patients

    Seq Age Sex Outcome Treatment
    1