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Adverse Event Report

CARDIOTRONICS SYSTEMS, INC. DIV OF BALLARD MEDICAL BALLARD MEDICAL/KIMBERLY-CLARK R2 PAD/ELECTRODE   back to search results
Catalog Number 3200-1715
Device Problem Arcing at electrodes
Event Date 08/24/2000
Patient Outcome  Other;
Event Description

During attempt to resuscitate pt with physio control lp/9 defibrillator, r2 pad arced and caught iv line, et tube, monitor-leads, as well as the pt's chest hair and beard on fire. Unable to revive pt. Failure of r2 pad was unrelated to death.

 
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Brand NameBALLARD MEDICAL/KIMBERLY-CLARK
Type of DeviceR2 PAD/ELECTRODE
Baseline Brand NameR2 PADS
Baseline Generic NameMULTIFUNCTION ELECTRODES
Baseline Catalogue Number3200-1715
Baseline Device FamilyR2 PADS
Baseline Device 510(K) NumberK964469
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)18
Date First Marketed12/01/1996
Manufacturer (Section F)
CARDIOTRONICS SYSTEMS, INC. DIV OF BALLARD MEDICAL
12050 lone peak parkway
draper UT 84020
Manufacturer (Section D)
BALLARD MEDICAL/KIMBERLY CLARK
12050 lane park parkway
draper UT 84020
Device Event Key284164
MDR Report Key293567
Event Key275655
Report Number293567
Device Sequence Number1
Product CodeMLN
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/24/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/01/2000
Device Catalogue Number3200-1715
Device LOT Number100255
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/24/2000
Distributor Facility Aware Date08/24/2000
Event Location Hospital
Date Report TO Manufacturer08/24/2000
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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