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

Model Number 3100A

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion file identification number is (b)(4).Any additional information that is provided by the customer will be included in a follow-up report.(b)(4).At this time, carefusion has not received the suspect device component for evaluation.

Event Description

The customer reported.While using the 3100a high frequency oscillating ventilator (hfov), the customer was unable to adjust the pressure from 39 centimeters (cm) to 43 cm.The customer reported the pressure regulator (pr) 3 was broken.The customer reported no patient involvement or allegation of patient harm.

• 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: 5186326
• MDR Text Key: 30245018
• Report Number: 2021710-2015-02082
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• 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