MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHRT G5 KIT,AUTO,INTL ENG-ARABIC,CPRD; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number G5A-06C

Device Problems Self-Activation or Keying (1557); Unintended Electrical Shock (4018)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

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 self discharged and the doctor received an unintended delivery of energy.Complainant indicated that there was no adverse effect to the patient and no information on the effects to the attending doctor due to the reported malfunction.

Manufacturer Narrative

The device was not received at zoll medical corporation for evaluation.Instead, the device logs were provided for evaluation.It is important to note that the device in use by this customer is an aed automatic device and is designed to analyze, prompt and provide a shock if necessary without input from the user.Review of the device activity logs for the customer's report of "device self discharge (without providing a warning prior to shock)" showed that there were multiple shock deliveries that occurred during this event.For each delivery, the shock was preceded by an analysis, a proper charge sequence and prompts both before and after the logged shocks.The customer later confirmed that the voice prompts were noted to be operational.The customer's report of "electrical shock to user" was attributed to the doctor being in contact with the patient at the time of the shock delivery.Review of the device logs did determine that the device performed as intended but certain factors cannot be determined without an actual evaluation of the device itself.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: POWERHRT G5 KIT,AUTO,INTL ENG-ARABIC,CPRD
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 12109183
• MDR Text Key: 259694614
• Report Number: 2112020-2021-00669
• 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: 06/14/2021

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-06C
• Device Catalogue Number: G5A-06C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other