MAUDE Adverse Event Report: CAREFUSION CAREFUSIION; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

The customer reported that the ventilator alarms seem to be off.No patient involvement.

Manufacturer Narrative

The customer evaluated the ventilator and determined that replacing the map panel meter fixed the issue with the alarms.

• Brand Name: CAREFUSIION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• 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: 4649662
• MDR Text Key: 5682189
• Report Number: 2021710-2015-00633
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P690057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/25/2015

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: 768901-103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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