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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORP. ONESTEP CPR COMPLETE MULTI FUNCTION ELECTRODE W / PACK

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ZOLL MEDICAL CORP. ONESTEP CPR COMPLETE MULTI FUNCTION ELECTRODE W / PACK Back to Search Results
Catalog Number 8900-0224-01
Device Problem Temperature Problem (3022)
Patient Problem Burn, Thermal (2530)
Event Date 12/08/2018
Event Type  Injury  
Event Description
After being paced by onestep zoll pads, the pt was found to have circular, small burn marks on the left lateral area of her body, below the breast. We believe that gel left on the sink from 12 lead ekg 3m red dot patches heated up during temporary pacer function use of pads, leading to burns until such time as a transcutaneous pacer could be placed.
 
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Brand NameONESTEP CPR COMPLETE
Type of DeviceMULTI FUNCTION ELECTRODE W / PACK
Manufacturer (Section D)
ZOLL MEDICAL CORP.
chelmsford MA 01824
MDR Report Key8164490
MDR Text Key130559466
Report NumberMW5082115
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
Type of Report Initial
Report Date 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/22/2020
Device Catalogue Number8900-0224-01
Device Lot Number3818D (SPECULATED)
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: 12/13/2018 Patient Sequence Number: 1
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