MAUDE Adverse Event Report: CAREFUSION CAREFUSION

Model Number 3100A

Device Problem Inaccurate Delivery (2339)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2015

Event Type  malfunction  

Event Description

The customer reported that although the ventilator pressurizes to specs (4), the pr3 regulator is at maximum.He also noticed that when the adjust knob is at the 1 o'clock position, the map is only at 14.

Manufacturer Narrative

(b)(4).Carefusion will evaluate the alleged failed park if it is returned to the manufacturer.

• Brand Name: CAREFUSION
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: wendy schumacher ; 7607787219
• MDR Report Key: 4798255
• MDR Text Key: 21928768
• Report Number: 2021710-2015-01028
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/23/2015

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: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1