Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORP. ZOLL X-SERIES EKG MONITOR; MONITOR, CARDIAC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZOLL MEDICAL CORP. ZOLL X-SERIES EKG MONITOR; MONITOR, CARDIAC Back to Search Results
Model Number X-SERIES
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2019
Event Type  malfunction  
Event Description
During a cardiac arrest case our zoll x-series ekg monitor did not give an ekg tracing in the 4-leads.The monitor was quickly replaced by other units ekg monitor.The delay was approx one min.Cpr was continued during delay.Zoll has been contacted and will conduct testing on the monitor.Our local county ems agency was also notified.During a cardiac arrest case our king vision video laryngoscope failed to operate correctly.The monitor screen was completely green and could not be used.Other airway interventions were continued and the pt was later intubated with a standard laryngoscope.The mfr and local ems agency was also notified of the event.Fda safety report ids# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ZOLL X-SERIES EKG MONITOR
Type of Device
MONITOR, CARDIAC
Manufacturer (Section D)
ZOLL MEDICAL CORP.
MDR Report Key9396607
MDR Text Key168787350
Report NumberMW5091371
Device Sequence Number1
Product Code DRT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/27/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberX-SERIES
Was Device Available for Evaluation? Yes
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 Number1
Patient Outcome(s) Other;
Patient Age92 YR
Patient Weight50
-
-