BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUNNELL

    MDR report key: 3784491 · Received March 24, 2014

    Report

    Report Number
    1719232-2014-00001
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 24, 2014
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) WAS CONTACTED FOR SOME FOLLOW-UP INFO. HE SAID THAT HE FIXED THE CARTRIDGE LID BY TIGHTENING THE SCREWS AND DEMONSTRATED TO THE RESPIRATORY THERAPIST, (B)(6), THAT THE CIRCUITS IN QUESTION, FOR OVERFILL, FILLED PROPERLY, AND THE VENT AND HUMIDIFIER FUNCTIONED APPROPRIATELY. (B)(6) SAID IF THE VENT WAS FIXED AND THE CIRCUITS WERE NOT TO BLAME THEN DON'T SEND THEM BACK TO BUNNELL. (B)(6) DISCARDED THE CIRCUITS WITHOUT RECORDING THE LOT#S. NO CIRCUITS OR OTHER EQUIPMENT WAS RETURNED TO BUNNELL FOR EVALUATION. THE CUSTOMER WAS CONFIDENT THAT THEIR BIOMED DEPARTMENT HAD RESOLVED THE ISSUE AND THERE WAS NO NEED FOR BUNNELL TO EVALUATE THE EQUIPMENT. THE PT SUFFERED NO INJURY, AND WAS RETURNED TO TREATMENT ON A NEW LIFE PULSE HFV.

    Description of Event or Problem · 1

    (B)(6) CALLED TO REPORT THAT THEY GOT A HIGH WATER LEVEL ALARM. THEY DID SOME TROUBLESHOOTING AND DECIDED TO CHANGE THE CIRCUIT. THE NEW CIRCUIT GENERATED A HIGH LEVEL ALARM AS WELL. WATER OVERFILLED THE CARTRIDGE AND WATER ENTERED THE CIRCUIT. THEY TOOK THE PT OFF THE LIFE PULSE, THINKING THIS MIGHT BE A VENTILATOR/HUMIDIFIER ISSUE. THE PT WAS STABILIZED BY MANUAL RESUSCITATION (BAGGING) WHILE THE VENTILATOR WAS SWITCHED OUT. THEY USED THE SAME CIRCUIT ON THE NEW VENTILATOR AND EVERYTHING WORKED PROPERLY. (B)(6), ONE OF (B)(6) BIOMED TECHS, SAID WAS ABLE TO DUPLICATE THE COMPLAINT OF WATER OVERFILL. HE SAID THE CARTRIDGE HOUSING LID WAS LOOSE, ALLOWING THE CARTRIDGE TO MOVE AROUND. HE TIGHTENED THE SCREWS HOLDING LID IN PLACE, THEN RETESTED THE SYSTEM USING ONE OF THE CIRCUITS INVOLVED IN THE COMPLAINT. THE CARTRIDGE FILLED NORMALLY AND NO ALARMS WERE GENERATED. HE FELT CONFIDENT THAT THE LOOSE LID/DOOR CAUSED THE PROBLEM. THE PT WAS STABILIZED BY HAND BAGGING WHILE THE VENTILATOR WAS SWITCHED OUT. HE WAS PLACED ON THE NEW LIFE PULSE HFV WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173452 BUNNELL LIFE PULSE HFV LSZ BUNNELL, INC. 203A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention