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

Model Number	9300A-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
The customer's report was observed during review of the device data logs.However, the device was put through extensive testing including functional stress testing without duplicating the report.An internal inspection found no discrepancies.The error was cleared from the logs.The device was recertified and returned to the customer.The electrode pads used were not returned as part of this investigation.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 was unable to obtain an ecg signal via electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: G3 AUTO, AED, AHA 2010, US ENGLISH, TSO
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 12276113
• Report Number: 2112020-2021-00732
• Device Sequence Number: 2825682
• Product Code: MKJ
• UDI-Device Identifier: 00812394021000
• UDI-Public: 00812394021000
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 9300A-1001-TSO
• Device Catalogue Number: 9300A-1001-TSO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1