• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL FOR VERMED / GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/VERMED/BIOM DEFIBRILLATION ELECTRODE 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 FOR VERMED / GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/VERMED/BIOM DEFIBRILLATION ELECTRODE AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Catalog Number C100AC-ZOLL
Device Problem Sparking (2595)
Patient Problem Insufficient Information (4580)
Event Date 11/25/2020
Event Type  malfunction  
Event Description
Visible spark noted during elective cardioversion (200j) from anterior proximal aspect of the defib pad where the wires connect to the actual physical pad. There was no gap in adhesion of the pads or other abnormalities noted with the pad upon visual inspection after the single shock delivered. There was a "normal" approximately 3cm x 5cm reddened area in the location of the defib pad contact. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEFIBRILLATION ELECTRODE
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL FOR VERMED / GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/VERMED/BIOM
buffalo NY 14204
MDR Report Key11108179
MDR Text Key225173159
Report NumberMW5098633
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC100AC-ZOLL
Device Lot NumberY101420-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/31/2020 Patient Sequence Number: 1
-
-