MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD EVAQUA; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR

Catalog Number RT235

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

Rn safety report: situation: at 0100 care time air found to be leaking around ventilator tubing, no vent alarms, pt getting tidal volumes without increasing peak pressures.Background: ega 26 week on vent support.Action: rt called to bedside, vent circuit changed, pt provided ppv with neotee during change over.Response: tubing saved for rt.Rn: when repositioning infant steady stream of air felt flowing from vent tubing close to y connector.The vent was not alarming.Pt getting adequate tidal volumes with pressures of 15-18 which was consistent with earlier in shift.Leak registered at 15-25%.Vent circuit changed and leak consistent.No change to baby's breath sounds, work of breathing pressure demands to meet tidal volumes and o2 reads stable throughout.Respiratory therapist(rt): vent circuit tubing audibly leaking, no alarms, patient's tidal volume remained within normal limits, no increase in peak pressure noted.Circuit tubing changed out while baby was neopuffed.Hole in tubing found near inspiratory connection.Rt also stated it could have been caused by the vent being too close to the isolette.There was a note placed on the circuit tubing that was removed that said "hole discovered on exhalation side where the tape was placed.".

• Brand Name: EVAQUA
• Type of Device: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15365 barranca parkway; irvine CA 92618
• MDR Report Key: 4095225
• MDR Text Key: 4831835
• Report Number: 4095225
• Device Sequence Number: 1
• Product Code: BZE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/16/2014

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 Catalogue Number: RT235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRAGER VENTILATOR; NO OTHER THERAPIES
• Patient Age: 8 DAY
• Patient Weight: 1