MAUDE Adverse Event Report: MERCURY MEDICAL NEO-TEE T-PIECE RESUSCITATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number 10-50838

Device Problem No Flow (2991)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/09/2023

Event Type  malfunction  

Event Description

Patient arrived via transport from another facility, patient's oxygen desaturated on cpap and had to be manually bagged with neotee.In the ambulance bay area, we arrived and saw that the doctor was using a neotee and the flow was not coming to patient.We continued to increase the positive end expiratory pressure (peep) and peak inspiratory pressure (pip) and saw no change in monometer movement.So we then changed out the neotee and the new one worked.

• Brand Name: NEO-TEE T-PIECE RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): MERCURY MEDICAL; 11300 49th st. north; clearwater FL 33762
• MDR Report Key: 16973459
• MDR Text Key: 315670414
• Report Number: 16973459
• Device Sequence Number: 1
• Product Code: BTL
• 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: 05/09/2023,04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 10-50838
• Device Catalogue Number: 10-50838
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2023
• Date Report to Manufacturer: 05/22/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male