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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Unable to set pip or peep on device.

• 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: 7082183
• Report Number: 7082183
• Device Sequence Number: 11246276
• Product Code: BTL
• UDI-Device Identifier: 10641043508114
• UDI-Public: (01)10641043508114
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2017
• Report Date (Section F): 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Model Number: 10-50811
• Device Catalogue Number: 1050811
• Device Lot Number: 1729350811
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/28/2017