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	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device was unable to analyze.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation, instead the device log was received.Review of the device log from the reported event concluded that the device worked as designed and within the limitations of the technology.Review of the log confirmed how this was reported by the customer; however, this is normal operation of the device.When the cpr cycle is interrupted mid cycle, the device will continue to perform cpr until it completes its cpr interval.In this case, the cpr cycle was interrupted due to the device detecting a valid impedance mid cycle.Once the cpr interval was over, the device analyzed as expected.This claim has been closed as device meets specification.Analysis of reports of this type has not identified an increase in trend.

• 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: 18613811
• Report Number: 2112020-2024-00044
• Device Sequence Number: 17996333
• Product Code: MKJ
• UDI-Device Identifier: 00812394021307
• UDI-Public: 00812394021307
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 01/10/2024

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-80C
• Device Catalogue Number: G5S-80C
• Was Device Available for Evaluation?: No
• 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: 01/10/2024
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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