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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE DATEX OHMEDA E-CAIO GAS MODULE; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
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GE HEALTHCARE DATEX OHMEDA E-CAIO GAS MODULE; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE Back to Search Results
Model Number E-CAIO-00
Device Problem Device Expiration Issue (1216)
Patient Problem No Information (3190)
Event Date 11/10/2017
Event Type  malfunction  
Event Description
We ordered the co2 absorber to perform preventive maintenance (pm) on the co2 module.The pm procedure states, "the co2 absorber is recommended to be replaced once in four years." we received 5 co2 absorber about a month ago and 4 of the 5 have an expiration date on them of 4 years from now, but the 5 has an expiration date of about 5 years from now.If the absorber is not to be replaced for 4 years then the parts that are being shipped should have a minimum expiration of 4 years as well.If we go by the recommendation we will have an expired absorber in our co2 module.
 
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Brand Name
DATEX OHMEDA E-CAIO GAS MODULE
Type of Device
ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
Manufacturer (Section D)
GE HEALTHCARE
8200 w tower ave
milwaukee WI 53223
MDR Report Key7099047
MDR Text Key94267698
Report Number7099047
Device Sequence Number1
Product Code CCL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberE-CAIO-00
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/10/2017
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer11/10/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
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