MAUDE Adverse Event Report: BUNNELL, INC. LIFEPORT; TUBE, TRACHEAL (W/WO CONNECTOR)

Device Problem Pressure Problem (3012)

Patient Problem Pneumothorax (2012)

Event Date 01/10/2015

Event Type  Injury  

Event Description

Respiratory therapist was told in a report, that the servo pressure on a high frequency jet ventilator (hfjv) was measuring at 6-7 all day.The therapist was called to the bedside by nurse to administer surfactant.They noticed that the servo pressure was measuring 4.3.Later that day, the respiratory therapist was called again to place inhalation inline with hfjv.At that time they noticed the servo pressure was measuring 5.6.A few hours later, a pneumothorax was confirmed by x-rays and the therapist then noticed the servo pressure was at 7.4-8.6.They notified the nnp and he told rt that they were performing a needle aspiration and chest tube on the right.Then, the respiratory therapist came by to do the q2 check and noticed the servo pressure was still 8.8-9.1.The therapist then called bunnell's hotline and asked for advice from the manufacturer.Bunnell (manufacturer) 3.5 adapter from the 2.5 one.Therapist called the other respiratory therapist on duty and she assisted in changing out the adapter.Patient tolerated the procedure fairly well.Oxygen saturation (sats) did drop in the 60 and 80s with bagging but responded well after placed back on hfjv with inhalation.Sats returned to 99 and 100.Immediately after placing pt back on hfjv, the servo pressure returned to 4.2-4.3 the rest of the shift.

• Brand Name: LIFEPORT
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale drive; salt lake city, UT 84115
• MDR Report Key: 4598241
• MDR Text Key: 15230831
• Report Number: 4598241
• Device Sequence Number: 1
• Product Code: CBI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HFJV
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 1 MO