MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. PEDIATRIC VENTILATOR CIRCUITS W/O PEEP; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number 10823X10

Device Problems Fracture (1260); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2018

Event Type  malfunction  

Event Description

Critical (b)(6) lb.Pediatric patient to be transported via aircraft.Shortly before arrival at hospital to pick up this patient, the flight crew was notified that they would be transporting a (b)(6) -month old intubated patient.A ventilator was not set-up before landing due to short notice.The flight crew arrived at the bedside to find non-intubated patient and the certified registered nurse anesthetist waiting for the helicopter emergency medical services team to assist.The patient was intubated and transported to the aircraft by bag-valve-mask.Ventilator tubing was removed from the pediatric bag and set up for use on the patient.It was attached to the patient and an error message was received, "!!!svhp relief." the patient's blood oxygen level dropped as well.Patient was removed from vent and bag-valve-mask was started with oxygen on.The patient's blood oxygen level went back up to 100%.Attempts to clear the error message were unsuccessful.It was then the crew member noticed that one of the sampling lines that is molding into the tubing had a fracture at the 90 degree attachment point.The crew bag-valve patient during flight without further issues.The crew was unable to replace this tubing during the flight as extra tubing is kept in the tail of the aircraft and is not accessible during the flight.No harm to patient due to active recovery by caregivers.

• Brand Name: PEDIATRIC VENTILATOR CIRCUITS W/O PEEP
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 1100 bird center dr.; palm springs CA 92262
• MDR Report Key: 7316506
• MDR Text Key: 101626935
• Report Number: 7316506
• Device Sequence Number: 1
• Product Code: CAI
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10823X10
• Device Lot Number: 150203
• Other Device ID Number: MANUFACTURER DATE 2015-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2018
• Device Age: 1 DY
• Event Location: Other
• Date Report to Manufacturer: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 YR