MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G3 PLUS AED; AUTOMATED EXTERNAL DEFIBRILLATOR (AED)

Model Number 9390E

Device Problem Failure to Sense (1559)

Patient Problems Cardiopulmonary Arrest (1765); Respiratory Failure (2484)

Event Date 02/26/2019

Event Type  Death  

Manufacturer Narrative

The customer was requested to send the aed to cardiac science for investigation.The electrodes are under the control of the judicial authorities and the customer is attempting to retrieve them for investigation.The lot number and expiration date of the electrodes are not currently available.

Event Description

The incident was reported to cardiac science by an ems in (b)(6).The ems responded to a call for a cardiac arrest on an infant and when their ambulance crew arrived, two (2) people were giving cpr.The ambulance crew took over the resuscitation and, after giving rescue breaths, the electrodes of the defibrillator were attached to the patient.After attaching the electrodes, the aed kept prompting the rescuers to "place electrodes".This continued until the lid of the aed was closed.The rescuers stated the electrodes were placed correctly on the patient.The ems reported that the patient had sudden infant death syndrome and could not be resuscitated.

Event Description

The incident was reported to cardiac science by an ems in belgium.The ems responded to a call for a cardiac arrest on an infant and when their ambulance crew arrived two people were giving cpr.The ambulance crew took over the resuscitation and, after giving rescue breaths, the electrodes of the defibrillator were attached to the patient.After attaching the electrodes the aed kept prompting the rescuers to "place electrodes".This continued until the lid of the aed was closed.The rescuers stated the electrodes were placed correctly on the patient.The ems reported that the patient had sudden infant death syndrome and could not be resuscitated.

Manufacturer Narrative

The aed was received at csc without any accessories.The pediatric pads used during the rescue could not be retrieved.It was reported that the pads remained attached to the patient when the body was claimed by the coroner.Despite multiple requests by the fire department, the coroner would not release the pads for evaluation.Multiple tests and inspections were performed.Several impedance tests were performed to confirm the aed could accurately detect impedance within the human impedance range and, consequently, recognize when pads were properly attached a patient.The aed successfully passed all impedance tests during the evaluation.Measurements of internal components that could impact the patient impedance circuit found no problems.Visual inspections of the main and ui pcbas also did not identify any problems.Simulated rescues were performed with the use of a defibrillator analyzer in an attempt to recreate the reported problem.The aed performed as designed during the simulations when used with both adult and pediatric pads.The reported issue was not duplicated and the aed operated correctly throughout the investigation.The root cause of the reported event could not be determined.Csc analyzed the returned aed and the device operated as intended.The pediatric electrodes used in the rescue attempt were not returned and could not be evaluated.Poor electrical contact between the pads and the patient due to damaged electrodes, skin condition, use error, or expired electrodes may be possible causes for the reported event.

• Brand Name: POWERHEART G3 PLUS AED
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR (AED)
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 8406197
• MDR Text Key: 138342185
• Report Number: 2112020-2019-00005
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: P160033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9390E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death