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

Model Number 204

Device Problems Circuit Failure (1089); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2023

Event Type  malfunction  

Event Description

While patient was out of bed with mother, jet alarmed "high level" referring to the water level in the heater.Patient was removed from jet ventilator and provided ventilation with t-piece resuscitator.Jet ventilator was put through a system test without resolution of alarm.Jet was power cycled and put through a second system test without resolution.Original circuit removed and new circuit placed, alarm resolved.Prior to placing patient back on jet ventilator, entire circuit flooded with water.Jet was removed from service and tagged, patient was placed on new jet ventilator without complication.Patient remained stable for duration.No patient harm.

• Brand Name: LIFEPULSE
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale dr.; s salt lake UT 84115
• MDR Report Key: 16806196
• MDR Text Key: 313935655
• Report Number: 16806196
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 204
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5 DA
• Patient Sex: Female