MAUDE Adverse Event Report: CAREFUSION 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100A - UPGRADE

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information that is provided by the customer will be included in a follow-up report.The customer did not provide patient demographics such as age, date of birth, gender, and weight.(b)(4).At this time, carefusion has not received the suspect device component for evaluation.

Event Description

The customer reported the pistol position indicator "vanished" on a 3100a ventilator while being used on a patient.The customer continued to use the device since the mean airway pressure (map) and the amplitude was being delivered properly.They are awaiting a replacement device to switch the patient on to.At this time, the customer did not report any patient harm or injury.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n. fairway drive; vernon hills, IL 60061 ; 2627587805
• MDR Report Key: 5199969
• MDR Text Key: 30616973
• Report Number: 2021710-2015-02129
• 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: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/05/2015

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 - UPGRADE
• Device Catalogue Number: 768901-RNT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2015
• Initial Date FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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