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

Model Number	9390A-1001
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to defibrillate a 97-year-old female patient, the device would not power up.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 has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The complainant was contacted for return of the device.The device has not been returned for evaluation.

• Brand Name: G3 PLUS AUTO, AED, AHA 2010, US 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: 15834023
• Report Number: 2112020-2022-01233
• Device Sequence Number: 5391196
• Product Code: MKJ
• UDI-Device Identifier: 00812394023271
• UDI-Public: 00812394023271
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 9390A-1001
• Device Catalogue Number: 9390A-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: 11/01/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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 Sex: Female