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

Model Number	G5S-80A
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	04/11/2024
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 63-year-old female patient, the device (sn (b)(6)) failed to discharge.Complainant indicated that the clinician obtained another device (sn (b)(6)) to continue treating the patient that also failed to discharge.The fire department used their device on the patient to continue treament and the device delivered the selected energy.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference sections d1 updated, d4 model # updated, d4 catalog # removed, d4 primary udi # updated.The device was returned to zoll medical corporation for evaluation.The customer's report was verified and attributed to the screen protector.The end user did not remove the screen protector which prevented the operator from being able to depress the shock button.Once the screen protector was removed, the device operated as intended.The device was recertified and returned to the customer.Zoll is looking into improving the design of the screen protector in an attempt to prevent such occurrences in the future.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: POWERHEART G5 KIT, SEMI, US ENG/ESP LA
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield MA 53531 9692
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 19231958
• Report Number: 2112020-2024-00329
• Device Sequence Number: 14869218
• Product Code: MKJ
• UDI-Device Identifier: 00812394021277
• UDI-Public: (01)00812394021277(21)D00000303256
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: G5S-80A
• Device Catalogue Number: G5S-80A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2324-2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(6), UDI (B)(4).
• Outcome Attributed to Adverse Event: Death
• Patient Age: 63 YR
• Patient Sex: Female