MAUDE Adverse Event Report: BUNNELL, INC. 2.5 MM LIFEPORT ADAPTERS; VENTILATOR, HIGH FREQUENCY

Lot Number 22042320

Device Problem Disconnection (1171)

Patient Problem Hypoventilation (1916)

Event Date 10/26/2022

Event Type  Injury  

Event Description

Describe event, problem, or product use error: patient was on hfjv with a 2.5 mm jet adaptor attached to ett.The jet adaptor repeatedly popped off from the ett disrupting ventilation of the patient.The jet adaptor was eventually changed to a larger size to prevent it from popping off.

• Brand Name: 2.5 MM LIFEPORT ADAPTERS
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INC.
• MDR Report Key: 15754480
• MDR Text Key: 303354295
• Report Number: MW5113137
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 22042320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 DA
• Patient Sex: Female
• Patient Weight: 1 KG
• Patient Ethnicity: Hispanic