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

Model Number G5A-80A

Device Problem Unable to Obtain Readings (1516)

Patient Problem Necrosis (1971)

Event Date 02/28/2024

Event Type  Death  

Event Description

Complainant alleged that while attempting to treat a female patient (age unknown), the device displayed a "check pads" message.Complainant indicated that the clinician obtained another set of defib pads to continue treating the patient, however, the same error was observed.The complainant indicated that the ems team arrived shortly after and their equipment was used to treat the patient with no success.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.The device was recertified and returned to the customer.Review of the data log showed the device properly identified pads connected, and no pads-related or device errors were detected other than user advisories to check pad connection to the patient.No trend is associated with reports of this type.An internal inspection resulted in no findings.

• Brand Name: POWERHEART G5 KIT, AUTO, US EN/LA ESP
• Type of Device: 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: 18952308
• MDR Text Key: 338268161
• Report Number: 2112020-2024-00228
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00812394020577
• UDI-Public: 00812394020577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

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
• Device Operator: Other
• Device Model Number: G5A-80A
• Device Catalogue Number: G5A-80A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female