MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, SEMI, UK; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number G5S-02A

Device Problems High impedance (1291); Unable to Obtain Readings (1516)

Patient Problem Necrosis (1971)

Event Date 08/11/2020

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the device did not detect the attached electrode pads and failed for high impedance.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, the device logs of the customer's report were provided.Review of the device log on the reported event date of (b)(6) 2020 showed the electrode connection and high impedance messages occurred after the event during the power off sequence.The device was rescue ready prior to the event and was able to detect a valid patient impedance and performed a series of analysis sessions as required during the event.Correct prompts were delivered to the user during the event and no errors were observed.The investigation concluded that the device met specifications and performed as designed.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: POWERHEART G5 KIT, SEMI, UK
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 11165366
• MDR Text Key: 226657772
• Report Number: 2112020-2021-00021
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: G5S-02A
• Device Catalogue Number: G5S-02A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death