• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KING SYSTEMS CORPORATION UNIVERSAL F2 ANESTHESIA BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KING SYSTEMS CORPORATION UNIVERSAL F2 ANESTHESIA BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Model Number LC395-6121Z
Device Problems Product Quality Problem (1506); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2021
Event Type  malfunction  
Event Description
Elbow gas sampling port on the king/ambu universal breathing circuit came loose after 4-hour procedure and we were unable to re-seat the cap. Previously, this was a luer-lock cap, but it has recently changed by the manufacturer to be a push-on cap. Manufacturer response for circuit, breathing (w connector, adaptor, y piece), universal f2 anesthesia breathing circuit (per site reporter): they will investigate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNIVERSAL F2 ANESTHESIA BREATHING CIRCUIT
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
KING SYSTEMS CORPORATION
15011 herriman blvd
noblesville IN 46060
MDR Report Key12804980
MDR Text Key280711627
Report Number12804980
Device Sequence Number1
Product Code CAI
UDI-Device Identifier00612649212166
UDI-Public(01)00612649212166(11)210910(17)230909(10)100057004
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLC395-6121Z
Device Catalogue NumberLC395-6121Z
Device Lot Number100057004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/03/2021
Event Location Hospital
Date Report to Manufacturer11/12/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-