MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G3 AED; AED (AUTOMATED EXTERNAL DEFIBRILLATOR)

Model Number 9300E

Device Problems Failure to Deliver Shock/Stimulation (1133); Intermittent Loss of Power (4016)

Patient Problems Cardiopulmonary Arrest (1765); Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

The aed has been received and an investigation is underway.

Event Description

When the event was initially reported to cardiac science, the reporter stated that during a rescue the aed advised a shock and then shut down.The customer was asked to provide more details about the event and the information provided included the following: we were dispatched for an unconscious male with unknown breathing status.Upon arrival we found the rather large patient lying on the floor next to his bed with agonal breathing.His wife stated she thought he was sleeping; unknown how long until she called 911.We checked for a pulse but could not find one.We used a stethoscope to listen to the chest but could not hear a heartbeat.We started cpr.The patient had a stoma but did not have his breathing tube in it, which made it difficult to get a good seal with a bvm which was hooked up to oxygen.We opened the aed and it told us to attach the pads to the patient's chest.Then it said: "do not touch the patient, analyzing." we stopped cpr for the analysis.After a few seconds the aed shut off and the screen showed "replace battery".We closed and reopened the lid a couple of times then the aed stated to "check electrodes" then "analyzing patient".And then" no shock advised, start cpr," which we did.Not at any point did it tell us to shock the patient.We continued cpr for two minutes and then the aed prompted "analyzing patient" again the aed stated no shock advised, and to start cpr, which we did for another two minutes.At this time the transporting ambulance arrived and their paramedic told us to remove our pads and he applied the pads from his heart monitor.He analyzed the rhythm and checked for a pulse.He also found the patient's breathing tube and inserted it in the patient's stoma.We continued to give breathes through the bvm while we loaded the patient onto a backboard to move him to the stretcher.The patient was loaded into the ambulance and the ambulance crew administered patient care to the hospital.Patient outcome is unknown.

• Brand Name: POWERHEART G3 AED
• Type of Device: AED (AUTOMATED EXTERNAL DEFIBRILLATOR)
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• Manufacturer (Section G): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• Manufacturer Contact: margo gisselberg ; 500 burdick parkway; deerfield, WI 53531-9692 ; 2629537950
• MDR Report Key: 8489800
• MDR Text Key: 141184659
• Report Number: 2112020-2019-00008
• Device Sequence Number: 1
• Product Code: MKJ
• 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
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2019

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?: Yes
• Device Operator: Other
• Device Model Number: 9300E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 04/06/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2010
• 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): Hospitalization; Life Threatening