PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
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Model Number 20 |
Device Problem
Failure to Sense (1559)
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Patient Problem
Death (1802)
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Event Date 06/03/2014 |
Event Type
Death
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Event Description
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The customer reported that the device had given multiple ¿connect electrodes¿ messages when attempting to defibrillate a patient which inhibited the use of the defibrillator.The patient, (b)(6) old male, had been taken to the emergency room (er) for care due to a spinal injury.The patient also suffered from an extreme case of subcutaneous emphysema (air pockets) under the skin.Physio-control contacted the er director for additional information and was advised that the er staff were able to deliver one defibrillation shock of 200 joules prior to the occurrence of the ¿connect electrodes¿ warning message.The er staff then retrieved a second device (also a lifepak® 20 defibrillator/monitor) as well as new set of defibrillation electrodes, but they continued to intermittently experience the same ¿connect electrodes¿ warning message which inhibited the use of the device to administer shocks to the patient.The er director stated that the er staff did not attempt to use the device hard-paddles to defibrillate the patient, in order to bypass the potential effects of the subcutaneous emphysema.The patient did not survive the event.
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Manufacturer Narrative
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(b)(4).Physio-control examined the customer's device.Proper operation was confirmed during functional and performance testing.The reported issue was not duplicated.The device was subsequently returned to the customer.Physio-control examined the electronic patient record from the event and confirmed the reported issue.Physio observed that the "connect electrodes" messages coincided with the er staff ceasing chest compressions.Due to the nature of subcutaneous emphysema, it is possible that while chest compressions were being administered the air pockets under the skin were compressed which reduced the patient¿s transthoracic impedance to a level which allowed the device to detect a valid patient connection.During the reported event, the patient's impedance was between 190 and 223 ohms when the patient connection was good.This is near the upper limit of the impedance range for a valid patient connection when the device is used with disposable defibrillation electrodes (upper limit = 300 ohms).When the chest compressions stopped during subsequent attempts to administer a shock, the patient's impedance likely rose to the point where the device could no longer detect the patient (300+ ohms) while using disposable defibrillation electrodes.Additionally, the er director at the facility advised that she believes it is possible that the extent of the patient's extreme subcutaneous emphysema may have caused the electrodes to be intermittently detected by the device.Based on the information available, it is likely that the cause of the reported issue was related to the patient's condition and not the result of a device malfunction.
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