MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 20

Device Problem Failure to Sense (1559)

Patient Problem Death (1802)

Event Date 06/03/2014

Event Type  Death  

Event Description

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, a (b)(6) 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 (reference physio submitted initial medwatch report number 3015876-2014-00767 for the first device).The er staff then retrieved a second device (referenced in this report) 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.

Manufacturer Narrative

(b)(4).Physio-control examined the customer's device.The reported issue was not duplicated.Repairs were then made which were unrelated to the reported issue and then proper operation was confirmed during functional and performance testing.The device was subsequently returned to the customer for use.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.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer Contact: jason march ; 4258674000
• MDR Report Key: 3914297
• MDR Text Key: 4666097
• Report Number: 3015876-2014-00768
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 3202488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 12 YR
• Event Location: Hospital
• Date Manufacturer Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 109