MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 AED SEMI-AUTOMATIC; AUTOMATED EXTERNAL DEFIBRILLATOR (AED)

Model Number	G5S
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer downloaded the rescue data file from the aed and sent the file and additional information about the rescue to cardiac science.The data is currently being reviewed.
Event or Problem Description
The fire fighter crew was the first on the scene of a cardiac arrest and attached their cardiac science aed to the patient.The aed analyzed the patient's rhythm and determined no shock was required.The paramedics arrived on the scene at approximately the same time as when cpr was started.The paramedics attached their pads to the patient and using their equipment immediately determined the patient was in vf and shocked the patient.The customer is questioning why the cardiac science aed did not advise a shock.Patient outcome is unknown.
Additional Manufacturer Narrative
Medical and technical reviews of the rescue data downloaded from the aed determined the aed had categorized the patient's vf rhythm as nonshockable due to high amplitude noise at the beginning of the first rhythm analysis period.No additional rhythm analyses were performed with the aed because the paramedics arrived on the scene and attached their defibrillator before a second analysis period could be performed.The aed was received at cardiac science and evaluated.The aed operated as designed and the reported problem could not be reproduced.No problems with the aed were found.The aed was serviced and returned to the customer.
Event or Problem Description
The fire fighter crew was the first on the scene of a cardiac arrest and attached their cardiac science aed to the patient.The aed analyzed the patient's rhythm and determined no shock was required.The paramedics arrived on the scene at approximately the same time as when cpr was started.The paramedics attached their pads to the patient and using their equipment immediately determined the patient was in vf and shocked the patient.The customer is questioning why the cardiac science aed did not advise a shock.Patient outcome is unknown.

• Brand Name: POWERHEART G5 AED SEMI-AUTOMATIC
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR (AED)
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 8172039
• Report Number: 2112020-2018-00027
• Device Sequence Number: 1459052
• Product Code: MKJ
• UDI-Device Identifier: 00812394021260
• UDI-Public: 00812394021260
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P160033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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
• Operator of Device: Other
• Device Model Number: G5S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening