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

Model Number KNCF370-6121Z

Device Problem Occlusion Within Device (1423)

Patient Problem Pulmonary Edema (2020)

Event Date 08/09/2017

Event Type  Injury  

Event Description

Per complainant, "the customer is reporting that something caused the hme part to get saturated and it caused back pressure.The negative pressure when the filter was taken off and they had to ventilate the patient.Doctor is reporting this caused the patient to get pulmonary edema.".

• Brand Name: UNIVERSAL FLEX2 BREATHING 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: 6851881
• MDR Text Key: 85350968
• Report Number: 1824226-2017-00005
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 00612649204826
• UDI-Public: (01)00612649204826
• 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
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2020
• Device Model Number: KNCF370-6121Z
• Device Catalogue Number: KNCF370-6121Z
• Device Lot Number: 2028376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• 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