MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. VITAL SIGNS; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Lot Number 0001190545

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/23/2018

Event Type  Injury  

Event Description

Found an anesthesia circuit with manufacturing issue-co2 elbow has no opening to allow testing.

• Brand Name: VITAL SIGNS
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 n. riverwoods blvd; mettawa IL 60045
• MDR Report Key: 7490172
• MDR Text Key: 107461257
• Report Number: 7490172
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2018,04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 0001190545
• Other Device ID Number: A46X29XX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Life Threatening; Other