MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES MONITOR DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number X SERIES

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Bradycardia (1751); Cardiopulmonary Arrest (1765); Myocardial Infarction (1969)

Event Date 09/22/2020

Event Type  Injury  

Event Description

Engine and medic 72 were dispatched to a medical aid in (b)(6).Engine 72 arrived first to the scene and utilized their equipment for the initial assessment/treatment.M72 arrived and continued treatment and transport utilizing the zoll cardiac monitor from e72.The patient was symptomatic bradycardic and positive for stemi on obtaining a 12 lead at scene.Upon loading the patient into the medic, cpr pads were placed anterior/posterior with the red square to the rear.Tcp was initiated at 80 bpm.Electrical capture was obtained at 50 ma, increased to 60 ma in an attempt to obtain mechanical capture, however, mechanical capture was never obtained as the patient fell into full cardiac arrest during c3 transport to (b)(6).At this time the pacer function was canceled by going into the pacer function menu, scrolling to and selecting "turn pacer off".At this time cpr was now being performed and there was no rhythm generated on the monitor when "pads" was displayed.The cpr device 'hockey puck' was applied to the patients chest.We were now receiving cpr feedback, however, still no rhythm was generated.I cycled the display to the 4 lead ecg so we could analyze and complete a pulse/rhythm check at the 2 minute interval.The monitor was pre-charged for defibrillation to 200j.Upon assessing the pulse and rhythm, the charged was dumped and cpr was continued.Throughout the resuscitation/transport the 4 lead ecg was utilized to perform rhythm analysis at the 2 minute intervals.We searched for the cause of the issue by confirming pad placement and assuring the cpr pads were connected to the grey/green port to the cardiac monitor.Please refer to the pcr or contact myself and the other crew members involved for additional information.The defib pads were not recovered after the event.The defibrillator has been shipped back to zoll for inspection.Fda safety report id# (b)(4).

• Brand Name: X SERIES MONITOR DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 10628078
• MDR Text Key: 210001092
• Report Number: MW5097054
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/30/2020

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 Model Number: X SERIES
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2020
• 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 Outcome(s): Life Threatening
• Patient Age: 73 YR
• Patient Weight: 79