MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION ST JOHN AMB G5 AED, AUTO, ADULT PADS; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number G5A-31A-SJA

Device Problem High impedance (1291)

Patient Problem Injection Site Reaction (4562)

Event Type  malfunction  

Event Description

Complainant alleged that during functional testing, the device failed for high impedance.Complainant did not indicate that there was any patient involvement in the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation for evaluation.The customer's report was not confirmed or replicated.The device was put through extensive testing including daily/weekly/monthly self-test and stress testing without duplicating the report.An internal inspection of the device found no discrepancies.The device was sent to inventory and a replacement device was sent to the customer.The pads were not returned as part of the evaluation.No trend is associated with reports of this type.

• Brand Name: ST JOHN AMB G5 AED, AUTO, ADULT PADS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 17871613
• MDR Text Key: 324931344
• Report Number: 2112020-2023-00916
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P160033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2023

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: G5A-31A-SJA
• Device Catalogue Number: G5A-31A-SJA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• 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