MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS GAS SAMPLING LINE, MULTIPATIENT, CONNECTOR, DISPOSABLE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Device Problem Disconnection (1171)

Patient Problems Cardiopulmonary Arrest (1765); Hypoxia (1918)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Vyaire has reached out to customer for additional information; however, no further information was available.An investigation could not be performed.If the customer provides product information or additional information, vyaire will provide a follow up emdr.

Event Description

It was reported to vyaire that there was a critical incident involving the disconnection of an (unknown part number) gas sampling line making correct placement of ett difficult to confirm.The customer states that the patient suffered hypoxia, airway obstruction, and cardio-respiratory arrest.Two cycles of cpr were given, 1mg adrenaline, reintubation eventually succeeded via bougie.Hypoxia lasting 3 - 5mins in total.Patient then stabilized whilst lightly anaesthetized.Decision was made to try to wake.Extubation then proceeded uneventfully with full recovery.The customer stated that an issue with the capnography line was identified.The capnography line was incorrectly connected and had sheared off making correct placement of ett difficult to confirm.The customer confirmed that no further patient harm was noted.

• Brand Name: VITAL SIGNS GAS SAMPLING LINE, MULTIPATIENT, CONNECTOR, DISPOSABLE
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): A&G LTD.; kadaka tee 46; tallinn,
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8686338
• MDR Text Key: 147572356
• Report Number: 3008264255-2019-00001
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention