MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION G3 PRO, AED, AHA 2010, ENGLISH; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	9300P-1001
Medical Device Problem Codes	Failure to Deliver Energy (1211); High impedance (1291); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that during biomed testing, the device's defib output was out of specification.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (device problem code).Evaluation: the device was returned to zoll medical corporation for evaluation.The customer's reports were observed during review of the device data logs.However, the device was put through extensive testing including bench handling, power cycling, and functional stress testing without duplicating the reports.The reports were cleared and did not reoccur.An internal inspection of the device found no discrepancies.Two sets of pads were returned with the device and were found to be expired.The pads were replaced as a precaution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that during biomed testing, the device's defib failed to deliver energy and failed for high impedance.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.

• Brand Name: G3 PRO, AED, AHA 2010, ENGLISH
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 12593901
• Report Number: 2112020-2021-01012
• Device Sequence Number: 1309065
• Product Code: MKJ
• UDI-Device Identifier: 00812394021048
• UDI-Public: 00812394021048
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2021

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: 9300P-1001
• Device Catalogue Number: 9300P-1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 09/16/2021; 09/16/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 10/30/2021; 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2018
• 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