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

Model Number	9390A
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	Seizures, Grand-Mal (2168)
Date of Event	08/24/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was having a grand mal seizure and was at risk for cardiac arrest.The nurses obtained the aed to be prepared in case the patient went into cardiac arrest.After pads were applied to the patient's chest, the aed continued to prompt the users to apply pads.A second set of pad was obtained and placed on the patient.The aed continued to prompt the users to "tear open foil package across dotted line and remove pads".The nurses continued to readjust the pads and plug / unplug the pads from the aed.The ems arrived and transported the patient to the local emergency department.The patient survived and returned to the facility within 24 hours.
Additional Manufacturer Narrative
The aed failed incoming impedance and energy tests.Inspection of the aed's patient connector, which is used to plug defibrillation pads into the aed, found damage inside the connector.A test connector was installed and the aed passed impedance and energy tests and the device functioned correctly.The damaged connector was determined to be the cause of the aed's failure to recognize pads during the reported event.The connector damage appears to be due to customer misuse.Aed was repaired and returned to the customer.Correction: usage of device was changed from unknown to reuse.
Event or Problem Description
The patient was having a grand mal seizure and was at risk for cardiac arrest.The nurses obtained the aed to be prepared in case the patient went into cardiac arrest.After pads were applied to the patient's chest, the aed continued to prompt the users to apply pads.A second set of pad was obtained and placed on the patient.The aed continued to prompt the users to "tear open foil package across dotted line and remove pads".The nurses continued to readjust the pads and plug / unplug the pads from the aed.The ems arrived and transported the patient to the local emergency department.The patient survived and returned to the facility within 24 hours.

• Brand Name: POWERHEART AED G3 PLUS AUTOMATIC
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; n7 w22025 johnson drive; waukesha WI 53186 1856
• MDR Report Key: 5958239
• Report Number: 2112020-2016-00009
• Device Sequence Number: 1451335
• Product Code: MKJ
• UDI-Device Identifier: 00812394020232
• UDI-Public: 00812394020232
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Model Number: 9390A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2016
• Supplement Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1