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

Model Number KN6903B-6121Z

Device Problem Fracture (1260)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event 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
• Type of Device: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): KING SYSTEMS; 15011 herriman blvd.; noblesvill IN 46060
• Manufacturer (Section G): KING SYSTEMS; 15011 herriman blvd.; noblesville IN 46060
• Manufacturer Contact: wayne nethercutt ; 15011 herriman blvd.; noblesville, IN 46060 ; 3177763175
• MDR Report Key: 6552199
• MDR Text Key: 74705115
• Report Number: 1824226-2017-00002
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 00612649204673
• UDI-Public: (01)00612649204673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: KN6903B-6121Z
• Device Catalogue Number: KN6903B-6121Z
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other