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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARMSTRONG MEDICAL LTD. AMSORB; ABSORBENT, CARBON-DIOXIDE
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ARMSTRONG MEDICAL LTD. AMSORB; ABSORBENT, CARBON-DIOXIDE Back to Search Results
Model Number AMAB3801-8
Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 12/22/2020
Event Type  malfunction  
Event Description
Over the last couple months it has been reported at two of our hospitals that the o e meyer amsorb carbon dioxide absorbers have been leaking.This issue is identified when the anesthesia gas machine does not pass its leak test.The canister is then removed and replaced with another canister, until the leak test is passed and the machine is working appropriately.This issue has been identified at both our hospital locations and seems to persist across several different lot numbers.Three of the lot numbers that were identified to have this issue include 170620f51, 17062of61, and 230420f112.The manufacturer replaced some of the affected product.
 
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Brand Name
AMSORB
Type of Device
ABSORBENT, CARBON-DIOXIDE
Manufacturer (Section D)
ARMSTRONG MEDICAL LTD.
7549 spring lake dr. no. c-2
bethesda MD 20817
MDR Report Key11146550
MDR Text Key226045604
Report Number11146550
Device Sequence Number1
Product Code CBL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAMAB3801-8
Device Lot Number230420F112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/06/2021
Event Location Hospital
Date Report to Manufacturer01/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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