BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOERNS B530 BED

    MDR report key: 7872241 · Received September 13, 2018

    Report

    Report Number
    3009402404-2018-00059
    Event Type
    Death
    Date Received
    September 13, 2018
    Date of Event
    January 21, 2017
    Report Date
    September 13, 2018
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EQUIPMENT INVOLVED: BILATERAL HALF SIDE RAILS WERE INSTALLED ON THE BED. BRAND NAME NOR MODEL NUMBER HAVE BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "PATIENT WAS FOUND UNRESPONSIVE AT APPROXIMATELY 2:20 A.M. WITH HIS HEAD TRAPPED BETWEEN THE MATTRESS AND SIDE RAIL OF HIS BED. THE CORONER DECLARED PATIENTS' CAUSE OF DEATH AS ASPHYXIA CAUSED BY NECK COMPRESSION THAT OCCURRED WHEN HIS HEAD WAS TRAPPED BETWEEN THE MATTRESS AND SIDE RAIL. THE MATTRESS PROVIDED TO THE FACILITY DID NOT FIT THE BED, LEAVING GAPS BETWEEN THE MATTRESS AND BED RAILS." COMPLAINT# (B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714878 JOERNS B530 BED ELECTRIC PATIENT BED FNL JOERNS HEALTHCARE B530

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death