MAUDE Adverse Event Report: ZOLL MEDICAL ZOLL X SERIES

Model Number X SERIES

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2017

Event Type  malfunction  

Event Description

Zoll x series monitor failed to defibrillate on second shock.Patient self converted seconds later, so did not suffer before of malfunction.The other monitor functions remained in working order on the remainder of the call.Afterwards, medics powered off monitor, then back on and it passed its self test.Zoll corporation technical supported notified, monitor removed from service and is being sent back to zoll for evaluation.

• Brand Name: ZOLL X SERIES
• Type of Device: ZOLL X SERIES
• Manufacturer (Section D): ZOLL MEDICAL
• MDR Report Key: 7154370
• MDR Text Key: 96212923
• Report Number: MW5074287
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2017
• 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: 62 YR
• Patient Weight: 82