MAUDE Adverse Event Report: BUNNELL, INC. LIFE PULSE; VENTILATOR, HIGH FREQENCY

Model Number 203A

Device Problems Device Displays Incorrect Message (2591); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

The bunnell life pulse high frequency ventilator was not working on six month old female premature infant in nicu.The nurse called the respiratory therapist to troubleshoot.Received a ventilator default code.Respiratory therapist called bunnell's hotline.Bunnell told the respiratory therapist to retest and still got the ventilator default code 03 after several retests.The respiratory therapist told bunnell that the servo pressure would not increase.Respiratory therapist took bunnell life pulse high frequency ventilator out of service and notified biomedical services.Replaced with a backup bunnell life pulse high frequency ventilator.No untoward effects to premature infant.

• Brand Name: LIFE PULSE
• Type of Device: VENTILATOR, HIGH FREQENCY
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• MDR Report Key: 3951921
• MDR Text Key: 4606206
• Report Number: 3951921
• Device Sequence Number: 1
• Product Code: LSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 203A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6 MO