MAUDE Adverse Event Report: KING SYSTEMS ADULT ULTRA FLEX ANESTHESIA BREATHING CIRCUIT

Model Number	KN6903B-6121Z
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
As reported by the complainant: the filter cracked at the junction of the elbow.The patient desaturated but is doing fine.

• Brand Name: ADULT ULTRA FLEX ANESTHESIA BREATHING CIRCUIT
• Common Device Name: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): KING SYSTEMS; 15011 herriman blvd.; noblesvill IN 46060
• MDR Report Key: 6552199
• Report Number: 1824226-2017-00002
• Device Sequence Number: 16402223
• Product Code: CAI
• UDI-Device Identifier: 00612649204673
• UDI-Public: (01)00612649204673
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K983817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2017

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
• Operator of Device: No Information
• Device Model Number: KN6903B-6121Z
• Device Catalogue Number: KN6903B-6121Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 05/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other