Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SODASORB; ABSORBENT, CARBON-DIOXIDE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. SODASORB; ABSORBENT, CARBON-DIOXIDE Back to Search Results
Model Number 008870
Device Problems Inadequate Instructions for Healthcare Professional (1319); Device Operates Differently Than Expected (2913)
Patient Problem Respiratory Distress (2045)
Event Date 12/14/2017
Event Type  malfunction  
Event Description
The design of the product allows for the product to be placed in the anesthesia machine (mindray) upside down and once the absorbent is exhausted and wet the canister cannot be released from the holder.The upper circumference of the canister is marginally larger than the bottom; however there is no notation on the supply to indicate how the canister should be placed in the holder i.E.This end up, etc.One patient's etc02 reached 70 and required manual ventilation while the canister was removed from the holder.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SODASORB
Type of Device
ABSORBENT, CARBON-DIOXIDE
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
1265 grey fox rd
saint paul MN 55112
MDR Report Key7178130
MDR Text Key96842576
Report Number7178130
Device Sequence Number1
Product Code CBL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number008870
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/20/2017
Event Location Hospital
Date Report to Manufacturer12/20/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/10/2018
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 OTHER THERAPIES; THE PRODUCT IS USED IN OUR ANESTHESIA MACHINES
-
-