• 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 CORPORATION M SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

  • 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 CORPORATION M SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number M-SERIES
Device Problem Failure to Read Input Signal (1581)
Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Event Date 08/16/2019
Event Type  malfunction  
Event Description
Patient went into vfib arrest.The zoll on the cart would charge to the intended 200 j but was unable to shock."ppr pad connect" displayed.Pads in place and plugged in properly.Equipment removed rom service and tagged for repair.Defib test ok after malfunction.Replacement zoll quickly pulled and used on patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
M SERIES
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key16814601
MDR Text Key314012983
Report Number16814601
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/19/2023,08/20/2019
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 NumberM-SERIES
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2023
Event Location Hospital
Date Report to Manufacturer04/26/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/26/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age17520 DA
Patient SexMale
-
-