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

Model Number	9300P-1001
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
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 monitor a 57-year-old male patient, the device issued a "shock advised" prompt for a heart rhythm they believe was non-shockable.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation.Instead the customer indicated the device advised a shock shortly after the patient regained consciousness.Please note that the indications for use are for the patient to be unresponsive, not breathing and without pulse.The customer indicated the device appears to be working again after removing and installing a new set of pads to the device.Therefore, the device is not being returned to zoll for servicing.Based on the information given, this claim has been closed as device worked as intended.No trend is associated with reports of this type.

• 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: 15115499
• Report Number: 2112020-2022-00780
• Device Sequence Number: 5874753
• Product Code: MKJ
• UDI-Device Identifier: 00812394023233
• UDI-Public: 00812394023233
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 07/06/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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 Age: 57 YR
• Patient Sex: Male