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

Model Number	G5S-80C
Medical Device Problem Codes	High impedance (1291); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
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 and failed for high impedance.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to 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 and three sets of g5 adult electrode pads (one with lot# 230309-09 and two with lot# 230619-04) were returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The electrode pads were recieved opened and stuck together.All three sets of pads passed continuity testing and were able to provide an ecg signal and shock into an analyzer.The device was put through extensive testing without duplicating the report.An internal inspection of the device found no discrepancies.Review of the device log found no evidence of the report.There are no errors present before or during the patient event.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.An error 505 does not affect the device's ability to be used clinically.This does not meet our criteria for reportability.
Additional Manufacturer Narrative
This supplemental medwatch report updates information based upon your request which differs from the initial medwatch report filed.Please reference sections d1 updated, d4 catalog # removed, d4 primary udi # updated.

• Brand Name: POWERHEART G5 KIT,SEMI, US ENG/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: 18170179
• Report Number: 2112020-2023-01050
• Device Sequence Number: 15366770
• Product Code: MKJ
• UDI-Device Identifier: 00812394021307
• UDI-Public: (01)00812394021307(21)D00000196981
• 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): 11/02/2023

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: 11/09/2023
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023; Not provided
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/18/2023; 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• 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