• 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 ZOLL PRO-PADZ 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 ZOLL PRO-PADZ AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Lot Number 0819
Device Problem Device Emits Odor (1425)
Patient Problem Burn, Thermal (2530)
Event Date 03/11/2019
Event Type  malfunction  
Event Description
A cath lab pt sustained a small burn under the pad site used for cardioversion. The pt was undergoing an afib cryo ablation. A zoll pad was placed on the left lateral chest of the pt. Cardioversion was attempted at 14:33 and again 14:34. At 15:20, the left lateral pad was removed and a new zoll pad was placed on the left anterior chest. At 15:24, another cardioversion was attempted. At 15:25, the team noticed a "burnt" smell and discovered a small circular burn under the zoll pad. The physician examined the site and noted that it looked like a small "rash. " the pt denied pain post procedure and when the site was checked several hours later, the pt denied pain or discomfort. The pads were not expired and/or dried out and there were no ripples or bubbles underneath the pad. The pad was not placed on a tattoo and it was the correct pad for the procedure. The vendor was also notified of this event. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZOLL PRO-PADZ
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
chelmsford MA 01824
MDR Report Key8565102
MDR Text Key143678985
Report NumberMW5086259
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
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 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/23/2020
Device Lot Number0819
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: 04/29/2019 Patient Sequence Number: 1
-
-