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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY E-CAIOV S/5 COMPACT AIRWAY MODULE; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
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GE HEALTHCARE FINLAND OY E-CAIOV S/5 COMPACT AIRWAY MODULE; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE Back to Search Results
Device Problems Application Program Problem: Dose Calculation Error (1189); Device Operates Differently Than Expected (2913)
Patient Problem Death (1802)
Event Date 01/31/2014
Event Type  Death  
Event Description
This record reports a ge healthcare module was being used during a dental procedure in which the pt coded and subsequently expired.The physician reports there is a difference in the percentage of anesthesia agent he dials in and the percentage computed by the module.
 
Manufacturer Narrative
Pt weight: pt weight was not provided.A follow-up report will be submitted when the investigation is complete.
 
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Brand Name
E-CAIOV S/5 COMPACT AIRWAY MODULE
Type of Device
ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
Manufacturer (Section D)
GE HEALTHCARE FINLAND OY
helsinki
FI 
Manufacturer (Section G)
GE HEALTHCARE
Manufacturer Contact
joy sonsalla
3000 n. grandview blvd
waukesha, WI 53188
2625482661
MDR Report Key3687387
MDR Text Key18298366
Report Number9610105-2014-00002
Device Sequence Number1
Product Code CCL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K051092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other
Type of Report Initial
Report Date 02/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/13/2014
Initial Date FDA Received03/11/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age9 YR
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