MAUDE Adverse Event Report: BUNNELL, INCORPORATED BUNNELL; VENTILATOR, HIGH FREQUENCY

Device Problems Device Alarm System (1012); Loss of Power (1475)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/16/2019

Event Type  malfunction  

Event Description

Bunnell jet alarm going off respiratory therapist (rt) went over to check found jet stopped and reset to default settings, infant desaturating to low 80's.There was no noted glitch or flicker in electricity.Checked circuit to make sure all connections were secure, tight and nothing was kinked.Reset appropriate settings and restarted jet.This happened 2x's more and error code 05 was seen on jet screen, and then rt proceeded to switch out jet.Error code 05 is an electrical irregularity has disrupted the microprocessor, corrective action was to power off life pule for 3-4 mins and then power back on.Rt opted to change out device.

• Brand Name: BUNNELL
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INCORPORATED; 436 lawndale dr.; s salt lake UT 84115
• MDR Report Key: 9145073
• MDR Text Key: 160890060
• Report Number: 9145073
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18 DA