MAUDE Adverse Event Report: BUNNELL, INCORPORATED LIFEPULSE HIGH FREQUENCY VENTILATOR; VENTILATOR, HIGH FREQUENCY

Model Number 203

Device Problems Failure to Align (2522); Connection Problem (2900)

Patient Problems Pneumothorax (2012); Respiratory Acidosis (2482)

Event Date 07/26/2022

Event Type  Injury  

Event Description

Neonate with normal initial blood gas upon arrival to the nicu (neonatal intensive care unit), placed on jet vent for respiratory support.Subsequently, blood gas showed patient (pt) severely acidotic.Jet set to jpeep of 7, peep pressure reading noted to be 10, 12, & 15 over 12 hours.Pt developed pneumothorax.Chest tube inserted without improvement of acidosis.Later discovered that jet tubing was slightly misaligned from the pinch valve in the patient box.Once misalignment corrected, acidosis improved drastically.

• Brand Name: LIFEPULSE HIGH FREQUENCY VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INCORPORATED; 436 lawndale dr; s salt lake UT 84115
• MDR Report Key: 15257634
• MDR Text Key: 298217195
• Report Number: 15257634
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 21 DA
• Patient Sex: Male
• Patient Weight: 1 KG
• Patient Race: Black Or African American