MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION AED, G5 SEMI, POWERHEART, US ENGLISH; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	G5S-01C
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device internally dumped the energy after charging up to defibrillate the patient.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The device was subjected to extensive testing including defib and analyze testing without duplicating the report.The device was recertified and returned to the customer.Review of the device log showed the device dumped the charge due to a change in the patient's rhythm (non-shockable).This is normal operation of the device.The powerheart g5 incorporates the patented rhythmx® software technology.By design, the aed will initiate a charge during the cpr period prior to the start of the analysis.After a shock decision is made, the shock is considered "non-committed", and the software continues to analyze the ecg.If there happens to be a change to a rhythm seen as non-shockable by the software, prior to a shock being delivered, the aed will cancel the shock.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED, G5 SEMI, POWERHEART, US ENGLISH
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 17198293
• Report Number: 2112020-2023-00538
• Device Sequence Number: 5684360
• Product Code: MKJ
• UDI-Device Identifier: 00812394021260
• UDI-Public: 00812394021260
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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: Other
• Device Model Number: G5S-01C
• Device Catalogue Number: G5S-01C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown