BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN

    MDR report key: 7533800 · Received May 22, 2018

    Report

    Report Number
    3003801933-2018-00001
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Report Date
    April 16, 2018
    Manufacturer
    EEZCARE MEDICAL CORP.
    Product Code
    FNM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAD GIVEN EFFORTS, BUT CAN NOT OBTAIN ANY MORE INFORMATION OR SUSPECT DEVICE RETURN FROM INITIAL REPORTER OR IMPORTER FOR EVALUATION. WE HAD SIMULATE THE SITUATION AS "DESCRIBE EVENT OR PROBLEM" MANY TIMES, EVEN WITH THE WORST CONDITION, BUT THE RESULT SHOW THAT "THE PATIENT SLID OUT OF HIS BED FACE DOWN ONTO HIS HEAD" DID NOT HAPPEN. THE SUSPECT DEVICE (AIR PUMP) WILL SHOW VISIBLE LOW PRESSURE ALARM IF THE TWO CELLS WERE LEAKING ON THE DEVICE,9 AND 10, THAT ARE FLAT. SO REASONABLE CONCLUSION THAT THE ROOT CAUSE OF ADVERSE EVENT HAPPENING IS NOT THE SUSPECT DEVICE MER-5800, BUT SOME UNKNOWN SITUATION THAT HAD NOT OBTAINED IN THIS REPORT. AS THE ATTACHED FILE "ADVERSE EVENT SIMULATION TEST REPORT".

    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 HAS 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
    376949 MERIDIAN 8 HOMECARE APM FNM EEZCARE MEDICAL CORP. MER-5800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other