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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MARQUETTE CLII PLUS ELECTROSURGICAL

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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MARQUETTE CLII PLUS ELECTROSURGICAL Back to Search Results
Model Number CLAB II PLUS 128
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Code Available (3191)
Event Date 06/12/2015
Event Type  Malfunction  
Event Description

A patient was on the ep lab 2 table with multiple catheters via both femoral veins, and right radial arterial line intubated with general anesthesia. Atrial fibrillation with radio frequency ablation procedure was initiated with three ablations occurring with carto 3 mapping system and intracardiac echocardiogram occurring. A message came across cardio lab stating clab ii amplifier not responding with a harsh odor of something burning. Procedure was aborted. Heparin drip stopped. Oxygen supply to ep lab 2 was shut off and anesthesia connected patient to portable supplements. Patient was awakened and extubated with vital signs stable.

 
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Brand NameMARQUETTE CLII PLUS
Type of DeviceELECTROSURGICAL
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
9900 w. innovation drive
wauwatosa WI 53226
MDR Report Key4858642
MDR Text Key21556177
Report Number4858642
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/12/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator INVALID DATA
Device MODEL NumberCLAB II PLUS 128
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/12/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/12/2015
Device Age10 yr
Event Location Hospital
Date Report TO Manufacturer06/22/2015

Patient TREATMENT DATA
Date Received: 06/12/2015 Patient Sequence Number: 1
Treatment
CARDIAC DRUGS; OTHER EQUIPMENT WAS USED ON THE PATIENT AT THE; ANESTHESIA ON VENTILATOR, GENERAL ELECTRIC CARDIO; TIME INCLUDING, CARTO 3 MAPPING, GENERAL; OTHER
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