BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPER JET

    MDR report key: 3808349 · Received April 2, 2014

    Report

    Report Number
    1719232-2014-00002
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 23, 2014
    Report Date
    April 28, 2014
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) (RESPIRATORY THERAPIST) REPORTED THAT THE PATIENT BOX WAS SET-UP ON A PATIENT BUT WOULD NOT READ THE PEEP, THE PEEP DISPLAY WAS ZERO. HE PULLED THE LIFE PULSE SYSTEM (VENT AND PB) AND PLACED THE PATIENT ON (B)(6) 2014 A DIFFERENT LIFE PULSE VENTILATOR WHICH WORKED FINE. THE DID TROUBLESHOOTING ON THE VENT (S/N (B)(4)) WITH A DIFFERENT PB AND THE VENT WORKED FINE. THEY RAN THE PB 4587 ON A DIFFERENT VENT AND HAD THE SAME RESULT, NO PEEP. THE PB WILL BE RETURNED TO BUNNEL FOR SERVICE AFTER IT IS RELEASE BY RISK MANAGEMENT. THERE WAS NO PATIENT INJURY ASSOCIATED WITH SWITCHING THE LIFE PULSE SYSTEMS. THE PATIENT BOX HAS BEEN SERVICED AT THE RECOMMENDED ANNUAL INTERVALS, WITH THE LAST SERVICE (B)(4) 2013. IF THE PATIENT BOX IS RETURNED FOR EVALUATION, THIS MEDWATCH REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A COPY OF THE MEDWATCH REPORT (B)(4) WAS RECEIVED FROM THE FDA. UNTIL THAT DATE, BUNNELL WAS UNAWARE OF THIS SITUATION. BUNNELL CONTACTED THE CUSTOMER AND INITIATED A FORMAL BUNNELL CUSTOMER COMPLAINT. EARLIER THIS YEAR, THE PATIENT WAS ON A JET VENTILATOR WHEN IT WAS NOTED THAT THE DEVICE WOULD NOT DELIVER THE PROGRAMMED SETTING. THE INFANT WAS TAKEN OFF THE JET VENTILATOR AND PROVIDED POSITIVE PRESSURE VENTILATION FOR 40 MINUTES. THE JET VENTILATOR WAS CHANGED TO ANOTHER JET VENTILATOR TO FINISH THE TREATMENT. WHAT WAS THE INTENDED PROCEDURE: HIGH FREQUENCY MECHANICAL VENTILATION. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199913 WHISPER JET VENTILATOR, HIGH FREQUENCY LSZ BUNNELL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO