MAUDE Adverse Event Report: KING SYSTEMS CORPORATION KINGSYSTEMS UNIVERSAL FLEX 2 CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number 0652

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

Kingsystems universal flex 2 circuit had a visible crack, compromising patient's ventilation.Circuit was immediately replaced, and proper ventilation established.Product info: kingsystems #0652, ref df4116-6121z, lot 1000818106, exp 03/07/2025.

• Brand Name: KINGSYSTEMS UNIVERSAL FLEX 2 CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): KING SYSTEMS CORPORATION
• MDR Report Key: 16832713
• MDR Text Key: 314276303
• Report Number: MW5117096
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0652
• Device Catalogue Number: DF4116-6121Z
• Device Lot Number: 1000818106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: White