BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRATION LS VENTILATOR

    MDR report key: 1690033 · Received May 7, 2010

    Report

    Report Number
    3003638180-2010-00001
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    July 29, 2008
    Report Date
    May 5, 2010
    Manufacturer
    EVENT MEDICAL LTD
    Product Code
    CBK
    PMA / PMN Number
    K072590
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING MADE AS A RESULT OF OUR REVIEW OF PAST COMPLAINT RECORDS. IT WAS NOTED DURING THE REVIEW THAT THIS COMPLAINT HAD NOT BEEN REPORTED IN 2008 AND SHOULD HAVE BEEN REPORTED AT THAT TIME. THEREFORE, WE ARE MAKING THE REPORT NOW. THE PROBLEM WITH THE VENTILATOR WAS RESOLVED BY THE DISTRIBUTOR INSTALLING A NEW RIBBON CABLE TO PCB INSIDE THE VENTILATOR. THE VENTILATOR HAS WORKED FINE WITH NO FURTHER COMPLAINTS SINCE 2008. NO PT INJURY OR DEATH RESULTED FROM THIS EVENT.

    Description of Event or Problem · 1

    AN OLD VENTILATOR (LS MODEL), THAT WAS DELIVERING TO A PT, SUDDENLY STOPPED AND THE MESSAGES OF TECHNICAL FAULT 12 AND 14 WERE ON THE DISPLAY. THE CAREGIVER SHUT DOWN THE VENTILATOR AND TURNED IT ON AGAIN. THE VENT. STARTED TO WORK PROPERLY AND AFTER 24 HOURS IT STOPPED AGAIN WITH TF 13 AND 17.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRATION LS VENTILATOR RESPIRATORY VENTILATOR CBK EVENT MEDICAL LTD LS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention