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

Model Number	10-50811
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Would never allow you to set a peep [positive end-expiratory pressure].Tried several different radiant warmers to make sure, flow was set to 10lpm, able to get a pip [peak inspiratory pressure] level set, but when you turn the dial for peep it stays at 0 and will not allow for peep so unable to give cpap [continuous positive airway pressure] to newborn infant.I tried several with this lot number and three of them would not set the peep.

• Brand Name: NEO-TEE T-PIECE RESUSCITATOR
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): MERCURY ENTERPRISES, INC.; 11300 49th st. north; clearwater FL 33762
• MDR Report Key: 23988450
• Report Number: 23988450
• Device Sequence Number: 4694765
• Product Code: BTL
• UDI-Device Identifier: 10641043508114
• UDI-Public: (01)10641043508114
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2025
• Report Date (Section F): 12/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 10-50811
• Device Catalogue Number: 1050811
• Device Lot Number: WO38965
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/16/2025