MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR

Model Number 203A

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Aspiration/Inhalation (1725); Hypoxia (1918)

Event Date 03/24/2015

Event Type  Injury  

Event Description

(b)(6) called on (b)(6) 2015 to report that water was delivered to a pt on the lifepulse (sn (b)(4)).The pt had to be manually ventilated to recover from a significant drop in oxygenation.The life pulse (b)(4) was removed and replaced with another life pulse ventilator.The pt recovered and appears to be ok with no obvious signs of injury.The delay in recording this event was due to an inability to get the ventilator serial number, the circuit lot number, or any details of the event from the respiratory therapy or biomed departments.The customer was called multiple times to obtain this info which was not reported to bunnell until (b)(6) 2015.Part of the problem was that the ventilator was sent to the biomed dept following the incident and the biomed dept is in a separate building on the (b)(6).The alarm reported by the respiratory therapist was high temp - cartridge which is unassociated with water level.Bunnell's clinical specialist had the respiratory therapist and biomed tech test the system, while on the phone with bunnell, on (b)(6) 2015.The circuit was left on the ventilator so it was requested that the customer empty the water out of the humidifier cartridge, reinstall the circuit and run it through the internal system test and operational test using a test lung.The system passed the system test and the operational tests.The humidifier cartridge filled to the normal operating level and stopped filling appropriately.During the twenty minute phone call there were no issues with the humidifier maintaining the normal water level.The humidifier did alarm high temp cartridge during testing indicating that the cartridge thermistor probably has an issue.They were going to leave the system running for 72 hours to see if the water level sensing changed.They will send the vent and circuit to bunnell for investigation at the end of the eval.

Manufacturer Narrative

User facility is currently performing internal eval of device.They have committed to return the hfv unit to bunnell for eval once testing is completed.Bunnell eval and testing will be completed if/when the hfv system is returned to bunnell.

• Brand Name: BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR
• Manufacturer (Section D): BUNNELL, INC.; salt lake city UT
• Manufacturer Contact: curtis olsen ; 436 lawndale dr.; salt lake city, UT 84115 ; 8014670800
• MDR Report Key: 4665737
• MDR Text Key: 5679220
• Report Number: 1719232-2015-00003
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 203A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention