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

Model Number 203

Device Problems Loss of Power (1475); Pressure Problem (3012); Ventilation Problem in Device Environment (3027)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2016

Event Type  malfunction  

Event Description

Earlier this year, a bunnell instruments ventilator stopped working while in use.No patient harm was reported as a respiratory therapist was able to manually support the patient.The unit stopped venting after being operating normally for a couple of days.A sudden ventilator fault alarm went off, causing the unit to go into standby and dashes were displayed on the display panel.Rt at bedside turned the ventilator off and back on, ran through self test which ventilator passed.Unit was replaced by another ventilator to be able to properly conduct an incident investigation.Unit was check with manufacturer and were able to reproduced the same problem.It was found that an intermittent servo pressure transducer would cause a false servo pressure display of 19.6 psi which would cause the system to generate random loss of pip, cannot meet pip and vent fault 10 alarms which would cause the vent to stop venting.The servo pressure transducer was replaced which restored system stability and a complete system calibration was performed with no drift over time observed.

• Brand Name: BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL INSTRUMENTS INC.; 436 lawndale drive; salt lake city UT 84115
• MDR Report Key: 5669332
• MDR Text Key: 45597037
• Report Number: 5669332
• Device Sequence Number: 1
• Product Code: LSZ
• 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: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2016
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1