MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL X SERIES MONITOR; MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Model Number X-SERIES

Device Problems Failure to Deliver Shock/Stimulation (1133); Pacing Problem (1439)

Patient Problems Cardiac Arrest (1762); Tachycardia (2095)

Event Date 08/31/2021

Event Type  Injury  

Event Description

During transport, patient was noted to have a small run of v-tach before going into sustained v-tach with a pulse.Patient initially remained gcs 15 and answering questions, but began to deteriorate.Monitor was synchronized with r-waves and charged to 200j.Unable to deliver synchronized cardioversion due to monitor malfunction.Pads were applied and the monitor was successfully synchronized with the qrs complexes.Monites was charged to 200j and the shock button was pressed.The monitor gave an error (synchronization error, defibrillator disarmed).And disarmed automatically.Process was repeated and error occurred again.Patient lost pulses, manual chest compressions started.Oxygen administered via non-rebreather.Epinephrine administered iv.Unsynchronized defibrillation administered at 200j and compressions resumed.Upon subsequent rhythm check, patient was noted to have return of spontaneous circulation.Fda safety report id # (b)(4).

• Brand Name: ZOLL X SERIES MONITOR
• Type of Device: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 12421365
• MDR Text Key: 270081737
• Report Number: MW5103699
• Device Sequence Number: 1
• Product Code: DRT
• 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: 08/31/2021

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?: 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: 09/02/2021
• 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; Other
• Patient Age: 83 YR
• Patient Weight: 59