BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 793659 · Received November 22, 2006

    Report

    Report Number
    1719232-2006-00004
    Event Type
    Other
    Date Received
    November 22, 2006
    Report Date
    November 22, 2006
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    p850064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED SYMPTOM OF "VENT FAULT" OR DEVICE SHUT OFF COLD NOT BE REPRODUCED. DEVICE POWERED UP WITH NO PROBLEMS. THE 6000 HOUR PREVENTIVE MAINTENANCE PERFORMED WITH NO FAILED COMPONENTS OR DEVICE MALFUNCTION. DEVICE CHECKED FOR SENSITIVITY TO AC LINE VOLTAGE. DEVICE OPERATED TO BELOW 105 VAC WITHOUT RESETTING OR SHUTTING DOWN. DEVICE FOUND TO PERFORM ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE UNINTERRUPTIBLE POWER SOURCE (UPS) THE VENTILATOR WAS CONNECTED TO ALARMED FIRST. THEN THE LIFE PULSE VENTILATOR ALARMED "VENTILATOR FAULT" AND SHUT OFF (WENT INTO STANDBY MODE). THEY WERE NOT ABLE TO GET THE VENTILATOR BACK ON. THIS IS THE APPROPRIATE RESPONSE OF THE VENTILATOR TO A FLUCTUATION IN VOLTAGE. AFTER THE VENTILATOR FAULT ALARM, THE VENTILATOR HAS TO BE OFF FOR 3 MINUTES TO CLEAR THE MEMORY. ONCE THE MEMORY IS CLEARED, THE VENTILATOR WILL RESTART NORMALLY. THIS IS INCLUDED IN THE INSTRUCTIONS FOR USE. THE PATIENT WAS ON NITRIC OXIDE AT THE TIME OF THE INCIDENT. THE VENTILATOR WAS SWITCHED OUT WITH ANOTHER LIFE PULSE VENTILATOR. DURING THAT TIME, THE PATIENT WAS SUPPORTED ON MANUAL VENTILATION. DURING THAT TIME, THE PATIENT ARRESTED AND DIED. HAD THE CLINICIANS LEFT THE 1ST VENTILATOR OFF FOR THE REQUIRED 3 MINUTES AND RESTARTED IT, THE TIME THE PATIENT WAS OFF THE VENTILATOR MAY HAVE BEEN SHORTER. THE 24-HOUR HOT LINE TELEPHONE NUMBER IS AFFIXED TO THE VENTILATOR IN A VERY OBVIOUS WAY BUT NO CALL WAS RECEIVED FROM THE HOSPITAL. THE UPS CONNECTED TO THE VENTILATOR WAS NOT THE ONE SUPPLIED BY OR RECOMMENDED BY BUNNELL INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULSE HIGH FREQUENCY VENTILATOR VENTILATOR LSZ BUNNELL, INC. 203 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other