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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ANESTHESIA CIRCUIT BAG CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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MEDLINE INDUSTRIES, INC. ANESTHESIA CIRCUIT BAG CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Model Number ANESTHESIA TOTE
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 05/14/2021
Event Type  malfunction  
Event Description
Anesthesia circuit changed and system leak check performed and circuit compliance confirmed as should be the procedure with every anesthesia circuit change. After performing the anesthesia induction, (pushing meds) and beginning to assist the patient with manual ventilation the breathing bag on the anesthesia machine popped off due to having a crack in the bag housing. This caused the anesthesia team to urgently intubate the patient prior to planned timing while the anesthesia tech retrieved the ambu bag off the anesthesia machine so post intubation ventilation could be performed. A new breathing bag was placed on the anesthesia machine. Fda safety report id# (b)(4).
 
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Brand NameANESTHESIA CIRCUIT BAG
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
MDR Report Key11874685
MDR Text Key252693989
Report NumberMW5101512
Device Sequence Number1
Product Code CAI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 05/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberANESTHESIA TOTE
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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