AMSORB PLUS G-CAN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-23 for AMSORB PLUS G-CAN * manufactured by Armstrong Medical Ltd.

Event Text Entries

[1725312] Anesthesia machine alarmed. An air leak was detected and a small hole was found in the amsorb g-can co2 absorbent canister. Product removed from shelves and replaced with new product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1957911
MDR Report Key1957911
Date Received2010-12-23
Date of Report2010-12-23
Date of Event2010-12-08
Report Date2010-12-23
Date Reported to FDA2010-12-23
Date Added to Maude2011-01-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameAMSORB PLUS
Generic NameCARBON DIOXIDE ABSORBENT CANISTER
Product CodeCBL
Date Received2010-12-23
Model NumberG-CAN
Catalog Number*
Lot Number19071F11
ID Number*
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerARMSTRONG MEDICAL LTD
Manufacturer Address7549 SPRING LAKE DR. NO. C-2 BETHESDA MD 20817 US 20817


Patients

Patient NumberTreatmentOutcomeDate
10 2010-12-23

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