MAUDE Adverse Event Report: CAREFUSION CORP HIGH FREQUENCY OSCILLATORY VENTILATOR; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problems Failure to Cycle (1142); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2014

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

The carefusion field service tech evaluated the ventilator adn was unable to duplicate the customer report that the ventilator failed to cycle.Service history for the ventilator reveals that the carefusion field service tech had completed preventive maintenance, calibrations, and performance verifications on the ventilator for customer satisfaction.As a courtesy, a new 3100a ventilator has been installed at the customer site and an rga has been issued for 3100a serial number (b)(4).The carefusion clinical sales specialist is meeting with the customer to offer further support and training if needed.Should add'l info became available a follow up medwatch report will be submitted.

Manufacturer Narrative

This supplemental report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.The original date of awareness is (b)(6) 2014.This information was noted on (b)(6) 2014.

• Brand Name: HIGH FREQUENCY OSCILLATORY VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION CORP; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill cervera ; 7607787307
• MDR Report Key: 4181037
• MDR Text Key: 5090945
• Report Number: 2021710-2014-00057
• 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: Other,User Facility,other,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/01/2014,07/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2014
• Distributor Facility Aware Date: 07/26/2014
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 10/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 1 MO