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

Model Number	9300E-1001-TSO
Medical Device Problem Code	Unable to Obtain Readings (1516)
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.
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 sections d1 brand name updated, d4 catalog # removed, d4 primary udi # updated.Evaluation results: the device was returned to zoll medical corporation for evaluation.The customer's report was observed during review of the device data logs.However, the device was put through extensive testing including daily/weekly/monthly testing and stress testing without duplicating the report.An internal inspection found no discrepancies.The main board will be replaced as a precaution.The device will be 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 functional testing, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation for evaluation.Instead, the data file of the customer's report was provided.Review of the data file did show the error message related to the customer's report.However, without receipt of the device, root cause evaluation could not be performed.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: POWERHEART® AED G3 SEMI AUTOMATIC AED
• 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: 19171554
• Report Number: 2112020-2024-00303
• Device Sequence Number: 12608128
• Product Code: MKJ
• UDI-Device Identifier: 00812394023219
• UDI-Public: (01)00812394023219(21)4474732
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2024

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: 9300E-1001-TSO
• Device Catalogue Number: 9300E-1001-TSO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/24/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2015
• 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