BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARI10A BARIATRIC BED

    MDR report key: 11869042 · Received May 24, 2021

    Report

    Report Number
    3009402404-2021-00004
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 23, 2021
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    OSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT FST WAS AT (B)(6) DOING A PKP ON (B)(6) 2021. WHILE SHE WAS INSIDE THE FACILITY, A MAINTENANCE MAN HAPPENED TO BE WALKING BY THE FST'S SERVICE VEHICLE AND NOTICED SMOKE COMING OUT OF THE BACK, HE CALLED THE FIRE DEPARTMENT AND HE AND ANOTHER MAINTENANCE MAN GOT A FIRE EXTINGUISHER AND PUT THE FIRE OUT. ONCE THE FIRE DEPARTMENT GOT ON SCENE, THEY CHECKED TO ENSURE THERE WERE NO HOT SPOTS OR FLAMES. ONCE THAT WAS DONE, THE TECH CALLED MY (B)(6) TEAM LEAD AND MYSELF. WE GOT ON A THREE WAY CALL TO ENSURE ACCURATE DATA WAS GATHERED. I INSTRUCTED FST TO REMOVE THE BATTERY FROM THE FRAME AND TAKE PICS OF THE DAMAGED PRODUCT. ALSO, SHE WAS INSTRUCTED TO PLACE THE EFFECTED ITEMS IN THE "CLEAN QUARANTINE AREA" UNTIL I ARRIVE IN (B)(6) TOMORROW TO COMPLETE THIS QVR FORM. COMPLAINT #(B)(4) AND RA#(B)(4) WAS ENTERED INTO OUR SYSTEM TO HAVE THE BED, MATTRESS AND CONTROL UNIT RETURNED FOR INVESTIGATION. AS OF THIS WRITING, THE UNITS HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766234 BARI10A BARIATRIC BED BARIATRIC BED OSI JOERNS HEALTHCARE BARI10A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R