MAUDE Adverse Event Report: 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	03/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The manometer falls out of the patient circuit, there is nothing holding it in place.

• Brand Name: NEO-TEE T-PIECE RESUSCITATOR
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 9943310
• Report Number: 9943310
• Device Sequence Number: 3374853
• 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): 03/10/2020
• Report Date (Section F): 03/10/2020

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
• Operator of Device: No Information
• Device Model Number: 10-50811
• Device Catalogue Number: 10-50811
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/10/2020