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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMBU INC. AMBU KING ANESTHESIA BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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AMBU INC. AMBU KING ANESTHESIA BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Device Problems Product Quality Problem (1506); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/30/2021
Event Type  Injury  
Event Description
The elbow on the anesthesia circuit no longer has a luer lock cap, but rather a luer-slip cap, on one of the 2 sites on the circuit to connect the gas sampling line (it used to until about 1. 5 to 2 years ago). When the patient was masked, the cap "popped open". Due to quick action by the anesthesia staff, no harm was caused. However, this can lead to failure to administer oxygen to a patient and loss of closure of the anesthesia circuit. When i spoke to the manufacturer's rep about this in the past, thinking that this might have been a change due to covid related supply chain issues, i was told it was not. It was a conscious decision on the manufacturer's part, and would remain in place. This is not an isolated incident; it has happened to many practioners on multiple occasions. Fda safety report id# (b)(4).
 
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Brand NameAMBU KING ANESTHESIA BREATHING CIRCUIT
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
AMBU INC.
6230 old dobbin lane, ste 250
columbia MD 21045
MDR Report Key12266940
MDR Text Key264989181
Report NumberMW5102947
Device Sequence Number1
Product Code CAI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
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

Patient Treatment Data
Date Received: 08/02/2021 Patient Sequence Number: 1
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