MAUDE Adverse Event Report: CAREFUSION 203, INC REVEL; VENTILATOR, CONTINUOUS

Model Number 19260-001

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer was able to verify the reported problem.When the ventilator was powered on, it had an audible high pressure alarm condition and would not deliver any breaths.It is recommended that the pressure module be replaced to correct the reported problem.

Event Description

It was reported that the ventilator was stuck in a high pressure alarm condition and would not cycle.This ventilator was on an ambulance but was not connected to a patient when the reported problem occurred.

• Brand Name: REVEL
• Type of Device: VENTILATOR, CONTINUOUS
• Manufacturer (Section D): CAREFUSION 203, INC; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer (Section G): CAREFUSION 203, INC; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer Contact: jennifer huybrecht ; 7633988395
• MDR Report Key: 5040381
• MDR Text Key: 25191838
• Report Number: 2031702-2015-00192
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Other
• Report Date: 08/28/2015

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
• Device Model Number: 19260-001
• Device Catalogue Number: 19260-001
• Other Device ID Number: RMA 282615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1