MAUDE Adverse Event Report: VYAIRE MEDICAL INC. EOL VITAL SIGNS¿ STRAIGHT CONNECTOR, ADULT, REUSABLE; CONNECTOR, AIRWAY (EXTENSION)

Model Number EOL VITAL SIGNS¿ STRAIGHT CONNECTOR, ADULT, REUSABLE

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the anesthesia machine failed to measure pressure as it reported air leak.Per the manufacturer of the anesthesia machine, the leak came from the eol vital signs¿ straight connector, adult, reusable (clinical accessory).Per testing, no leak was detected with the anesthesia machine (no effect to ventilation).There is no patient or user harm associated with the incident.

• Brand Name: EOL VITAL SIGNS¿ STRAIGHT CONNECTOR, ADULT, REUSABLE
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12175925
• MDR Text Key: 263841751
• Report Number: 8010939-2021-00001
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EOL VITAL SIGNS¿ STRAIGHT CONNECTOR, ADULT, REUSABLE
• Device Catalogue Number: 8003460
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: No
• 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