BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIDIAN

    MDR report key: 7432207 · Received April 16, 2018

    Report

    Report Number
    3012316249-2018-00019
    Event Type
    Injury
    Date Received
    April 16, 2018
    Report Date
    April 16, 2018
    Manufacturer
    EEZCARE MEDICAL CORP.
    Product Code
    FNM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO CELLS WERE LEAKING ON THE DEVICE, 9 AND 10, THAT ARE FLAT. THE PATIENT SLID OUT OF HIS BED FACE DOWN ONTO HIS HEAD. THE PATIENT HAD A CONTUSION ON HIS HEAD. HE IS A VEGETATIVE PATIENT THAT DOESN'T MOVE. THEY HAD ONE BOLSTER ON THE OPPOSITE SIDE ONLY, THE SIDE THE PATIENT FELL DID NOT HAVE A BOLSTER. THE FACILITY SAID NO AUDIBLE OR VISIBLE ALARM WAS GOING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275328 MERIDIAN 8 HOMECARE APM FNM EEZCARE MEDICAL CORP. MER-5800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other