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

Model Number 9300A-1040

Device Problem Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that during training by facility staff, the device was unable to obtain an ecg signal via pads.Complainant did not indicate that there was any patient involvement in the reported malfunction.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, the data file of the customer's report was provided.Review of the data file did show the error message related to the customer's report.However, without receipt of the device, root cause evaluation could not be performed.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: G3 AUTO, AED, AHA 2010, INDONESIAN
• 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: 12634966
• MDR Text Key: 276590993
• Report Number: 2112020-2021-01040
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: ID
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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
• Device Operator: Other
• Device Model Number: 9300A-1040
• Device Catalogue Number: 9300A-1040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• 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