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

Model Number	G5A-80A-TSO
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that during functional testing, the device displayed an "ecg fault -501" error message.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.During the investigation, the technician discovered that the customer attempted to repair the device.As a result of the device being tampered with, the root cause could not be firmly established.The device succesfully passed daily/weekly/monthly self-tests, on/off current, patient and circuit impedance testing, and shock testing.Upon internal inspection, observed damages.Based on the damage, the device cannot be repaired.The device will be returned unrepaired and is deemed not for clinical use.Analyis of reports of this type has not identified an increase in trend.

• Brand Name: POWERHEART® G5 TSO KIT, AUTO, US EN/LA ESP
• Common Device Name: AUTOMATED EXTERNAL DISTRIBUTOR
• 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: 21970733
• Report Number: 2112020-2025-00277
• Device Sequence Number: 12880632
• Product Code: MKJ
• UDI-Device Identifier: 00812394021390
• UDI-Public: (01)00812394021390
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2025

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
• Operator of Device: Other
• Device Model Number: G5A-80A-TSO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown