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

Model Number 203

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

Bunnell was notified of this event on 07/18/2016 when a copy of user facility report (b)(4) was received via (b)(4) mail.Prior to receipt of this report, bunnell had not been notified of this event.There is no record of the user facility calling bunnell's 24/7 clinical hotline, in relation to this event.Following receipt of uf report (b)(4), several attempts were made to call the user facility for additional information; however, the contact number provided in the report was incomplete as a required extension was missing.Several attempts were then made to e-mail both the initial reporter and an additional contact within the respiratory care department at the user facility.No response was received to any of these attempted contacts.No device was returned to bunnell for evaluation, in relation to this event.A review of related device history (dhr) was not possible as the serial number reported in uf report (b)(4) is not a bunnell assigned serial number.Bunnell assigns a 4 digit numeric serial number to each hfv model 203; however, the user facility reported a serial number of (b)(4).Based on event description, it is likely that the device was responding appropriately to a set-up, environmental, or device condition by alerting the user to an alarm condition.As no investigation was possible, the cause of the alarm condition could not be determined.Bunnell's clinical hotline is available 24/7 to help troubleshoot alarm conditions.There is no record that the user facility called the helpline in relation to this event.

Event Description

As per user facility report (b)(4) event description: "called to bedside by rn for high frequency jet ventilator reading "cannot meet pip" took patient off and bagged to troubleshoot vent, rest and ran circuit check, placed patient back on high frequency jet ventilator.Within a few minutes, "cannot meet pip (positive inspiratory pressure) alarm went off again and then flashed "ventilator fault" patient was again removed from vent and bagged while troubleshooting.Would not let me push "enter" to restart jet, would not restart.Turned jet off and back on, would not restart but continued to say "ventilator fault".Jet pulled and replaced with new machine and new circuit.".

• Brand Name: BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR
• Type of Device: BUNNELL LIFE PULSE HFV
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• Manufacturer (Section G): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• Manufacturer Contact: curtis olsen ; 436 lawndale drive; salt lake city, UT 84115 ; 8014670800
• MDR Report Key: 5882148
• MDR Text Key: 52306848
• Report Number: 1719232-2016-00004
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other