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

Model Number 9390E-1001

Device Problems Self-Activation or Keying (1557); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to defibrillate a male patient (age unknown), the device self discharged and the rescuer received an unintended delivery of energy.Complainant indicated that there was no adverse effect to the patient and no information on the effects to the rescuer due to the reported malfunction.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the device performed to specification.The device was recertified and returned to the customer.Review of the device activity logs showed two analyses performed during the approximate 5:52 length case.Both analyses result in a "no shock advised" prompt.There is no indication that the device ever charged or delivered a shock.If the device did deliver a shock, a shock delivered entry would be present, and the ecg waveform would show evidence of the delivery, wherein this case, it does not.Therefore, our investigation for this report was unsubstantiated.The device was put through extensive testing including electrical safety and functionality testing without duplicating a malfunction.The device was recertified and returned to the customer.No trend is associated with reports of this type.

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 e.Investigation: the customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.

• Brand Name: G3 PLUS, AED, AHA 2010, ENGLISH
• Type of Device: 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: 12499110
• MDR Text Key: 272269085
• Report Number: 2112020-2021-00904
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00812394021116
• UDI-Public: 00812394021116
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 9390E-1001
• Device Catalogue Number: 9390E-1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other