MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,SEMI,KOR-INTL ENG; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	G5S-19A
Medical Device Problem Codes	Unable to Obtain Readings (1516); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that during biomed testing, the device prompted a "unit failed" message and was unable to detect the attached electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The customer's report of the device prompted a "unit failed" message was verified and attributed to corrupted firmware.It is unknown what caused the firmware to become corrupted.The device firmware was reloaded to remedy the report.The customer's report of the device was unable to detect the attached electrode pads was observed during review of the device data logs.However, the device was put through extensive testing without duplicating the report.An internal inspection found no discrepancies.The defib pads used during the event were not returned as part of this investigation.Analysis of reports of this type has not identified an increase in trend.The device was recertified and returned to the customer.

• Brand Name: POWERHEART G5 KIT,SEMI,KOR-INTL ENG
• Common Device Name: 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: 18578826
• Report Number: 2112020-2024-00021
• Device Sequence Number: 7852895
• Product Code: MKJ
• UDI-Device Identifier: 00812394023141
• UDI-Public: 00812394023141
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P160033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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: G5S-19A
• Device Catalogue Number: G5S-19A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2016
• 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