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

Model Number KN60903B-6121Z

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2021

Event Type  Injury  

Event Description

Reaching circuit for anesthesia machine repeatedly cracks.Fda safety report id # (b)(4).

• Brand Name: KING ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): KING SYSTEMS; noblesville IN 46960
• MDR Report Key: 12967504
• MDR Text Key: 282040899
• Report Number: MW5105935
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2022
• Device Model Number: KN60903B-6121Z
• Device Lot Number: 100458884
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White