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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARMSTRONG MEDICAL LTD AMSORB® PLUS; ABSORBENT, CARBON-DIOXIDE
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ARMSTRONG MEDICAL LTD AMSORB® PLUS; ABSORBENT, CARBON-DIOXIDE Back to Search Results
Model Number AMAB3803GE
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/29/2022
Event Type  malfunction  
Event Description
Amsorb plus disposable canisters are leaking on the anesthesia machines.Manufacturer response for amsorb plus disposable canister, amsorb plus prefilled care-can absorber canister, 1.4l, 8 per case (carestation) (per site reporter).Hello, today we tested (2) amsorb plus canisters that had been set aside.Only (1) failed the self-check.The other canister passed.I dropped off (3) replacement canisters and took the (1) bad one.I have reported the lot number 101221f511 to the ge team.I will let you know if there is a known issue tied to lot 101221f511.
 
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Brand Name
AMSORB® PLUS
Type of Device
ABSORBENT, CARBON-DIOXIDE
Manufacturer (Section D)
ARMSTRONG MEDICAL LTD
11403 empire ln
rockville MD 20852
MDR Report Key14929024
MDR Text Key295321854
Report Number14929024
Device Sequence Number1
Product Code CBL
UDI-Device Identifier2105489006
UDI-Public2105489-006
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAMAB3803GE
Device Catalogue Number2105489-006
Device Lot Number101221F511
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/23/2022
Event Location Hospital
Date Report to Manufacturer07/06/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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