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

Model Number X-SERIES

Device Problem No Display/Image (1183)

Patient Problem Cardiac Arrest (1762)

Event Date 11/10/2019

Event Type  Injury  

Event Description

During pt care, out zoll x-series stopped showing the cardiac ekg rhythm for two brief periods.The ekg monitor was attached to the pt with zoll crp stat padz.The pt was in cardiac arrest and treatment was continued during period of no ekg rhythm.Zoll service rep (b)(4) was notified of the issue was tested the ekg monitor.The monitor passed the inspection.The stat padz were not retained but left on the pt at the (b)(6) hospital (b)(6).Ekg monitor passed mfr's inspection and testing.Fda safety report id# (b)(4).

• Brand Name: X-SERIES
• Type of Device: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER AND RATE ALARM)
• Manufacturer (Section D): ZOLL MEDICAL CORP.
• MDR Report Key: 9341353
• MDR Text Key: 167133397
• Report Number: MW5091152
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Age: 21 YR