MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, AUTO, US EN/LA ESP, CPRD; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number G5A-80C

Device Problem Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that during functional, the device displayed a "check pads" message.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Evaluation: the device was returned to zoll medical corporation for evaluation.The customer's report was observed during initial testing.However, after disassembling the device to determine root cause, the report was no longer seen.The main board and electrode receptacle connector were replaced as a precaution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: POWERHEART G5 KIT, AUTO, US EN/LA ESP, CPRD
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 12586536
• MDR Text Key: 275921761
• Report Number: 2112020-2021-01006
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00812394021222
• UDI-Public: 00812394021222
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

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: G5A-80C
• Device Catalogue Number: G5A-80C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 10/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1