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

Model Number 203

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2017

Event Type  malfunction  

Event Description

Ventilator alarmed high pip (peak inspiratory pressure), self cycled in an attempt to reset.Alarmed high pip again and then shut down reading ventilator fault.Patient was hand ventilated and suffered no harm until another vent was used.Manufacturer response for ventilator, life pulse high frequency ventilator (per site reporter).None yet.

• Brand Name: LIFE PULSE HIGH FREQUENCY VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale dr.; s salt lake UT 84115
• MDR Report Key: 6689078
• MDR Text Key: 79141373
• Report Number: 6689078
• 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: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 203
• Device Lot Number: A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: N/A.; NOT APPLICABLE.