BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFE PULSE HIGH FREQ. VENTILATOR W/PATIENTBOX

    MDR report key: 1003069 · Received February 25, 2008

    Report

    Report Number
    1719232-2008-00001
    Event Type
    Other
    Date Received
    February 25, 2008
    Date of Event
    October 29, 2007
    Report Date
    February 25, 2007
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNMENT OF THE PINCH VALVE ASSEMBLY WAS EVALUATED. THE SPRING MOUNTING BRACKET WAS REPLACED WITH IMPROVED CLEARANCE RELATIVE TO THE CRACK PRESSURE SPRING. THE PINCH VALVE DISK SHAFT WAS POLISHED AND THE BEARING RE-LUBRICATED ON RE-ASSEMBLY. THE ROLLING DIAPHRAGM WAS ASSURED TO BE PROPERLY CENTER/ALIGNED. TO ENSURE OPTIMAL ALIGNMENT, THE PINCH VALVE HEAD SLOT WAS ADJUSTED BY 0.015 INCH ON ONE SIDE.

    Description of Event or Problem · 1

    HOSPITAL REPORTED A PROBLEM THAT HE STATED HE SUSPECTED WAS NOT A PROBLEM WITH OUR DEVICE BUT WAS ACTUALLY USER ERROR. A NOTE FROM HIM ACCOMPANIED THE VENTILATOR AND PATIENT BOX WHEN THEY WERE RETURNED TO US. IT STATED THAT THE DEVICE WAS IN USE ON A PATIENT WHO DEVELOPED A PNEUMOTHORAX SUSPECTED TO BE RELATED TO A BOLUS OF AIR BEING DELIVERED DURING A NON-READY CONDITION. IT FURTHER STATED THEIR BIOMED. DEPT. COULD FIND NO PROBLEM WITH OUR DEVICE. THE REPORTED SYMPTOM OF A BOLUS OF AIR IN THE NON-READY CONDITION WOULD BE ASSOCIATED WITH THE USER PRESSING THE ENTER BUTTON WHILE THE VENTILATOR WAS OPERATING WHICH IS CONTRARY TO OUR INSTRUCTIONS. A BOLUS OF AIR CANNOT BE ACHIEVED FROM STANDBY. IN ADDITION, NO ALARM CONDITIONS WERE IDENTIFIED BY THE USER. THE PATIENT BOX WAS CHECKED FOR HAVING SUFFERED AN IMPACT (FROM BEING DROPPED) AND NO DAMAGE WAS FOUND. AFTER SEVERAL DAYS OF RUNNING THE PATIENT BOX STOPPED CYCLING BUT WITH A LOSS OF PIP AND MAP LIMIT ALARMS. THE USER DID NOT REPORT ANY ALARM CONDITIONS IN ASSOCIATION WITH THIS EVENT. IN ADDITION, THIS WOULD NOT HAVE CAUSED A BOLUS OF AIR TO BE DELIVERED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULSE HIGH FREQ. VENTILATOR W/PATIENTBOX HIGH FREQUENCY VENTILATOR LSZ BUNNELL, INC. 203A/312 7G0245

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention