MAUDE Adverse Event Report: KING SYSTEMS UNIVERSAL FLEX2 CIRCUIT; ANESTHESIA BREATHING CIRCUIT

Model Number KNCF470-6121Z

Device Problem Misassembled (1398)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/20/2017

Event Type  malfunction  

Event Description

Patient's sat level fell.The clinicians began troubleshooting, during which time the patient was manually ventilated.It was discovered that the inner hose at the machine end of the breathing circuit was separated from the breathing filter.The breathing circuit was replaced and patient outcome was unaffected.

Manufacturer Narrative

Updated sections due to evaluation of the device.

• Brand Name: UNIVERSAL FLEX2 CIRCUIT
• Type of Device: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): KING SYSTEMS; 15011 herriman blvd.; noblesville 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: 6412770
• MDR Text Key: 70335254
• Report Number: 1824226-2017-00001
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 00612649175867
• UDI-Public: (01)00612649175867
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2020
• Device Model Number: KNCF470-6121Z
• Device Catalogue Number: KNCF470-6121Z
• Device Lot Number: 1985605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2017
• 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