MAUDE Adverse Event Report: ZOLL MEDICAL CORP. ZOLL X-SERIES EKG MONITOR; MONITOR, CARDIAC

Model Number X-SERIES

Device Problem Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Event Description

During a cardiac arrest case of our zoll x-series ekg monitor did not give an ekg tracing / rhythm.Cpr was continued while a second monitor from another unit on the scene was retrieved.The second monitor was applied without a problem and pt care continued.The ekg monitor was current with it's annual testing by zoll.The monitor will be sent to zoll for testing.The county ems agency was also notified of the event.Fda safety report id# (b)(4).

• Brand Name: ZOLL X-SERIES EKG MONITOR
• Type of Device: MONITOR, CARDIAC
• Manufacturer (Section D): ZOLL MEDICAL CORP.
• MDR Report Key: 9396788
• MDR Text Key: 168787243
• Report Number: MW5091374
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/27/2019

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: 11/29/2019
• 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): Other
• Patient Age: 82 YR
• Patient Weight: 64