MAUDE Adverse Event Report: MERCURY MEDICAL T-PIECE NEONATAL PATIENT CIRCUIT KIT; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number M1091335VS

Device Problems Device Slipped (1584); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2014

Event Type  No Answer Provided  

Event Description

Infant born via c-section required resuscitation using neopuff equipment.The equipment user experienced difficulty setting and maintaining the positive end expiratory pressure (peep).In her experience, the t-piece regulator valve she was using at this time was loose and would not lock into place.The loose valve made it difficult to provide steady ppv, which was crucial to the newborn during this procedure.The newborn was safely resuscitated without an adverse event occurring.

• Brand Name: T-PIECE NEONATAL PATIENT CIRCUIT KIT
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): MERCURY MEDICAL; 11300 49th st. north; clearwater FL 33762
• MDR Report Key: 3868237
• MDR Text Key: 17384636
• Report Number: 3868237
• Device Sequence Number: 1
• Product Code: BTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Nurse
• Device Model Number: M1091335VS
• Device Lot Number: 14049
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1