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Adverse Event Report

CARDIOTRONICS SYSTEMS INC. A DIV. OF BALLARD MED. PRODUCT CARDIOTRONICS SYSTEMS INC. R-2 PADS/3200-610 ADULT   back to search results
Model Number 3200-610 ADULT
Device Problem Arcing at paddles
Event Date 02/17/1998
Patient Outcome  Other;
Event Description

Intervention on right coronary artery, ventricular fibrillation occurred, "cor-o" team arrived; auto defibrillator pads placed on pt; the pt's chest was very hairy, causing arc and burning pt's chest. Pt stabilized and intubated, burns treated with silvadine in the cardiac catheterization pads involved melted. As a result of this incident, facility is no longer using this type of pad.

 
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Brand NameCARDIOTRONICS SYSTEMS INC.
Type of DeviceR-2 PADS/3200-610 ADULT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CARDIOTRONICS SYSTEMS INC. A DIV. OF BALLARD MED. PRODUCT
12050 lone peak pkwy.
draper UT 84020
Manufacturer (Section D)
CARDIOTRONICS SYSTEMS INC. A DIV. OF BALLARD MED. PRODUCT
12050 lone peak pkwy.
draper UT 84020
Device Event Key163264
MDR Report Key167795
Event Key157676
Report Number167795
Device Sequence Number1
Product CodeMLN
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 05/11/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number3200-610 ADULT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/11/1998
Distributor Facility Aware Date02/24/1998
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer05/11/1998
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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