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

Model Number 9390A-1001

Device Problem Unable to Obtain Readings (1516)

Patient Problem Premature Labor (2465)

Event Type  malfunction  

Manufacturer Narrative

The customer's report was observed during review of the device logs.However, the device was put through extensive testing including periodic self-test and functional testing without duplicating the report.An internal inspection resulted in no findings.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 Description

Complainant alleged that during incoming testing, the device was unable to obtain ecg signal via pads.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: G3 PLUS AUTO, AED, AHA 2010, US 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: 10635609
• MDR Text Key: 210010102
• Report Number: 2112020-2020-00832
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2020

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
• Device Operator: Other
• Device Model Number: 9390A-1001
• Device Catalogue Number: 9390A-1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2015
• 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