MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. VITAL SIGNS¿; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number B1714XXX

Device Problems Defective Component (2292); Gas/Air Leak (2946)

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

Event Date 05/02/2023

Event Type  malfunction  

Event Description

Pediatric patient was sedated for intubation.Endotracheal (et) tube was placed by anesthesia and hooked up to the circuit.When patient was manually ventilated, it sounded like there was a leak in the circuit.Anesthesia noted there was not good ventilation like there was a leak happening.Et tube placement was good and sealed and on listening it sounded like it was the circuit.Decision was made to extubate the patient and try to bag and mask the patient while i and the scrub quickly changed the circuit tubing and bag.Once this was achieved, the sound of the leak was gone and better ventilation was achieved as well.More medication to sedate for intubation was done and the et replaced with good seal in the tube and the circuit was ventilating as it should be.This rn took the bad circuit and package for it and pulled the rest of the same lot numbered circuits out of the pediatric cart and were given to the charge rn.Manufacturer response for circuit, breathing (w connector, adaptor, y piece), vital signs¿ (per site reporter).No response yet from manufacturer, emailed twice after the event.User facility had previously been dealing with vyaire on this same issue earlier in the year.

• Brand Name: VITAL SIGNS¿
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 510 technology dr; irvine CA 92618
• MDR Report Key: 17049814
• MDR Text Key: 316420689
• Report Number: 17049814
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: B1714XXX
• Device Catalogue Number: B1714XXX
• Device Lot Number: 0004226339
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1825 DA
• Patient Sex: Female
• Patient Weight: 21 KG