MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION PEDIATRIC AED ELECTRODES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number REF 9730

Device Problems Defective Component (2292); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 10/25/2020

Event Type  malfunction  

Event Description

Note: this incident did not affect patient care.I am just reporting it because a piece of our ems equipment technically did fail during a call.We were called to assist a mutual aid department with an infant in full arrest with cpr in progress.While en route to the call, one of our personnel opened the aed and attached a set of pediatric electrodes, so that they were ready to use it for the call.The aed did not seem to recognize them, and kept stating "check pads" over and over.When the adult pads were plugged back into the machine, it recognized them and began normal functions.The problem was easily replicated back at the station after the call.Patient care was not affected by this incident, however- the mutual aid agency at the scene brought their aed inside without any delay.Also, the incident was one where our use of an aed would not have been of any help.This aed is covered under manufacturer's liability, and has been regularly maintained.I believe the problem is with the pediatric electrodes.Visual inspection of the pads in question yielded no imperfections/defects that we could see.They have been retained so that we could send them for testing/review.The manufacturer has asked for them to be sent in, and i informed them that we will be keeping them until all pertinent reporting agencies have been notified and indicate that they don't need them.Aed: cardiac science powerheart g3 semi-automatic s/n: (b)(4), electrodes: cardiac science pediatric, ref # 9730.Lot # 181029-01.Exp: 01-29-2021.Fda safety report id# (b)(4).

• Brand Name: PEDIATRIC AED ELECTRODES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION
• MDR Report Key: 10762385
• MDR Text Key: 214146653
• Report Number: MW5097560
• Device Sequence Number: 1
• Product Code: MKJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: REF 9730
• Device Lot Number: 181029-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 WK