BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E500 VENTILATOR

    MDR report key: 5824046 · Received July 26, 2016

    Report

    Report Number
    2023050-2016-00437
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    May 26, 2016
    Report Date
    June 28, 2016
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K061094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE NUMBER: (B)(4). MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED AND THE REPAIR COULD NOT BE VERIFIED. A NON-MEDTRONIC SERVICE PROVIDER CALIBRATED THE GDM BUT COULD NOT RESOLVE THE ISSUE. THE DEVICE WAS CONTINUOUSLY RUN FOR 72 HOURS WITHOUT ANY PROBLEMS. THE GAS DELIVERY UNIT (GDU) TO CPM CABLE CONNECTOR WAS FOUND TO BE CRACKED, WHEN THE CABLE WAS SHAKEN, THE FAILURE WAS GENERATED. VENTILATION CONTINUED BUT THE CPM TURNED OFF, THE DEVICE ALERT INDICATOR LIT, THE MONITOR FAILED AND THE COMM ERROR GENERATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE A VENTILATOR GENERATED A NON-SILENCABLE COMM ERROR, THE CONTROL PANEL MODULE (CPM) SHUT OFF AND THE GRAPHICS DISPLAY MONITOR (GDM) HAD VERTICAL LINES AND NOISE. THERE WAS NO PATIENT HARM/INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474899 E500 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC GDU1810

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention