MAUDE Adverse Event Report: UNETIXS VASCULAR, INC MULTILAB SERIES II ERGO-IDC; MONITOR,ULTRASONIC,NONFETAL

Model Number	11949-0000-01
Medical Device Problem Codes	Inflation Problem (1310); Pressure Problem (3012)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762); Nausea (1970)
Date of Event	11/23/2022
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2022- patient taken to radiology for abi.Ft tech and agency tech completing exam together.Abi air line connected to right-saline lock located in right ac.Error recognized when cuff was not inflating and air was not reaching maximum point.Exam stopped and lines disconnected.Patient reports feeling nauseous then suffers cardiac arrest.Patient placed on left side, ln trendelenburg position.Code blue initiated.On (b)(6) 2022 1452 ct chest without contrast: extensive portal venous gas is identified throughout the liver with patchy gas and air-fluid levels within the superior and inferior vena cava, right atrium and ventricle, subclavian veins and pulmonary arteries.A small amount of gas is present within the aortic arch as well.Diagnosis he under went abls today and there was an error during the test and pressurized air was injected into the peripheral iv.The patient subsequently had a cardiac arrest secondary to massive iatrogenic air embolism.- documented by dr.(b)(6)/cc review of incident related to machine : abi air-line male connector easily fits into both the intended blood pressure cuff and the saline helplock connected to the iv site.

• Brand Name: MULTILAB SERIES II ERGO-IDC
• Common Device Name: MONITOR,ULTRASONIC,NONFETAL
• Manufacturer (Section D): UNETIXS VASCULAR, INC; 333 strawberry field rd.; ste 11; warwick RI 02886
• MDR Report Key: 16015359
• Report Number: MW5113854
• Device Sequence Number: 6859200
• Product Code: JAF
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/08/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 11949-0000-01
• Device Catalogue Number: MULTILAB SERIES II ERGO-IDC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2022
• 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: Death
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White