MAUDE Adverse Event Report: CAREFUSION VENTILATOR

Device Problems Detachment Of Device Component (1104); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2018

Event Type  Injury  

Event Description

Pt admitted to nicu d/t prematurity.Vent noted to be alarming.Tubing kept popping off and alarming.Rt to bedside and made aware.Vent taken out of service and new vent replaced.No harm to pt.

• Brand Name: VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 7266543
• MDR Text Key: 100042753
• Report Number: MW5075200
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/09/2018

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 Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention