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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SODASORB CO2 ABSORBENT ABSORBER, CARBON-DIOXIDE PRODUCT CODE: BSF

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SMITHS MEDICAL ASD, INC. PORTEX SODASORB CO2 ABSORBENT ABSORBER, CARBON-DIOXIDE PRODUCT CODE: BSF Back to Search Results
Catalog Number 008870
Device Problems Absorber (CO2) (401); Failure to Cycle (1142)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

Information was received that a smiths medical portex sodasorb co2 absorbent was broken, which generated an "error" alarm on the machie. Event occured prior to use with a patient. No adverse effects were reported.

 
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Brand NamePORTEX SODASORB CO2 ABSORBENT
Type of DeviceABSORBER, CARBON-DIOXIDE PRODUCT CODE: BSF
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL LTD
boundary road
hythe, kent
UK
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key8499879
MDR Text Key141478993
Report Number3012307300-2019-01910
Device Sequence Number1
Product Code BSF
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 04/10/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/10/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue Number008870
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/08/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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