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

Model Number 9390A

Device Problem Failure to Sense (1559)

Patient Problem Seizures, Grand-Mal (2168)

Event Date 08/24/2016

Event Type  malfunction  

Event 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.

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 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
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; n7 w22025 johnson drive; waukesha WI 53186 1856
• Manufacturer (Section G): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• Manufacturer Contact: beverly magrane ; n7 w22025 johnson drive; waukesha, WI 53186-1856 ; 2629537951
• MDR Report Key: 5958239
• MDR Text Key: 54994503
• Report Number: 2112020-2016-00009
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00812394020232
• UDI-Public: 00812394020232
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 9390A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• 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