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

Model Number	G5S-80C
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device did not detect the attached electrode pads.Complainant indicated that the clinician changed to a different set of pads but still had the same error.The clinician then obtained another device sn (b)(6) to continue treating the patient.This device worked for one round of cpr but then also prompted a "check pads" message.An ems crew arrived on scence and took over care of the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The g5 device and two sets of g5 adult electrodes were returned to zoll medical corporation for evaluation.The device was put through extensive testing without duplicating the report.Both sets of g5 adult electrodes were received stuck together, one set had paper stuck to the gel, both passed testing including providing an ecg signal and shocking into an analyzer.The device log data was reviewed and determined the device operated as intended during the event.The device identified two different sets of pads connected.There were no pads-related errors present prior to or during the reported patient event.There was no rescue recorded because the g5 aed will not record a rescue unless a valid patient impedance is detected (between 20-250 ohms).This indicates a connection issue between the patient and the pads; however, we cannot determine pad placement, degree of skin prep, or if there are patient factors that may have contributed to the event.We have not identified an issue with the device or the pads that would have prevented a signal from being detected and subsequent shocks if required.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
This supplemental medwatch report updates information based upon your request which differs from the initial medwatch report filed.Please reference sections d4 catalog # removed, d4 primary udi # updated.

• Brand Name: POWERHEART G5 KIT,SEMI, US EN/LA ESP, CPRD
• 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: 18282771
• Report Number: 2112020-2023-01119
• Device Sequence Number: 6847012
• Product Code: MKJ
• UDI-Device Identifier: 00812394021307
• UDI-Public: (01)00812394021307(21)D00000199524
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2023

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
• Operator of Device: Other
• Device Model Number: G5S-80C
• Device Catalogue Number: G5S-80C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 11/16/2023; Not provided
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/24/2024; 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: G5, (B)(6)
• Patient Sex: Unknown