BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUNNELL LIFEPULSE MODEL 204

    MDR report key: 20055150 · Received August 23, 2024

    Report

    Report Number
    1719232-2024-00004
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    April 28, 2024
    Report Date
    August 21, 2024
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY DID NOT NOTIFY BUNNELL OF THIS EVENT DIRECTLY. IT WAS CONFIRMED THAT NO CALL WAS RECEIVED ON BUNNELL'S HOTLINE RELATED TO THIS EVENT. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. USER FACILITY REPORT (B)(4) RECEIVED FROM THE FDA ON 07/22/2024. USER FACILITY CONTACTED. CONFIRMED NO PATIENT INJURY. NO ADDITIONAL INFORMATION, IN ADDITION TO INFORMATION WITHIN THE USER FACILITY REPORT WAS PROVIDED. NO INVESTIGATION OF THE DEVICE POSSIBLE. THIS MANUFACTURER REPORT IS BEING SUBMITTED 08/21/2024 IN RESPONSE TO THE USER FACILITY REPORT.

    Additional Manufacturer Narrative · 0

    THE USER FACILITY DID NOT NOTIFY BUNNELL OF THIS EVENT DIRECTLY. IT WAS CONFIRMED THAT NO CALL WAS RECEIVED ON BUNNELL'S HOTLINE RELATED TO THIS EVENT. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. USER FACILITY REPORT (B)(4) RECEIVED FROM THE FDA ON 07/22/2024. USER FACILITY CONTACTED. CONFIRMED NO PATIENT INJURY. NO ADDITIONAL INFORMATION, IN ADDITION TO INFORMATION WITHIN THE USER FACILITY REPORT WAS PROVIDED. NO INVESTIGATION OF THE DEVICE POSSIBLE. THIS MANUFACTURER REPORT IS BEING SUBMITTED 08/21/2024 IN RESPONSE TO THE USER FACILITY REPORT. FOLLOW-UP REPORT SUBMITTED TO ADD USER FACILITY REPORT NUMBER TO SECTION H10.

    Description of Event or Problem · 0

    PER USER FACILITY REPORT (B)(4) (RECEIVED BY BUNNELL ON 07/22/2024): "AFTER SETTING UP A HIGH FREQUENCY JET VENTILATION (HFJV) AND RUNNING A PASSING TEST ON IT. IT WAS PLACED ON THE BABY, AND ONCE THE VENT STARTED TRYING TO PRESSURIZE ITSELF, IT WOULD DROP THE PRESSURE AND THE LOW PEAK INSPIRATORY PRESSURE (PIP) ALARMS WOULD SOUND. TUBING CHECKED TO MADE SURE THAT EVERYTHING WAS TIGHT AND RESPIRATORY RERAN THE TEST ON THE VENTILATOR AND IT PASSED AGAIN BUT WHEN PLACED THE VENT BACK ON THE BABY AGAIN IT DID HE EXACT SAME THING. AFTER ANOTHER ATTEMPT TO FIX IT THE VENT NOTED CIRCUIT FAILURE AND SPEWED WATER EVERYWHERE. VENT NOT USED ON THIS PATIENT. PATIENT BEING BAGGED DURING THE SET UP OF THE VENT. VENT SENT TO BIOMED FOR EVALUATION."

    Description of Event or Problem · 0

    PER USER FACILITY REPORT (B)(4) (RECEIVED BY BUNNELL ON 07/22/2024): "AFTER SETTING UP A HIGH FREQUENCY JET VENTILATION (HFJV) AND RUNNING A PASSING TEST ON IT. IT WAS PLACED ON THE BABY, AND ONCE THE VENT STARTED TRYING TO PRESSURIZE ITSELF, IT WOULD DROP THE PRESSURE AND THE LOW PEAK INSPIRATORY PRESSURE (PIP) ALARMS WOULD SOUND. TUBING CHECKED TO MADE SURE THAT EVERYTHING WAS TIGHT AND RESPIRATORY RERAN THE TEST ON THE VENTILATOR AND IT PASSED AGAIN BUT WHEN PLACED THE VENT BACK ON THE BABY AGAIN IT DID, HE EXACT SAME THING. AFTER ANOTHER ATTEMPT TO FIX IT, THE VENT NOTED CIRCUIT FAILURE AND SPEWED WATER EVERYWHERE. VENT NOT USED ON THIS PATIENT. PATIENT BEING BAGGED DURING THE SET UP OF THE VENT. VENT SENT TO BIOMED FOR EVALUATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699156 BUNNELL LIFEPULSE MODEL 204 LIFEPULSE HFV LSZ BUNNELL, INC. 204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown