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

Model Number 3100A

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2015

Event Type  Injury  

Event Description

The customer reported they found water on the blue line while on a pt, he claims this unit has the new cap/diaphragms, the pressure on the pressure meter was 7 cm.He is not able to duplicate the problem with a new circuit, he does not have the original circuit.The pt was removed from this unit and placed on a conventional ventilator, no pt harm.

Manufacturer Narrative

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

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.

• Brand Name: HIGH FREQUENCY OSCILLATORY VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY/LSZ
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 7149227830
• MDR Report Key: 4804398
• MDR Text Key: 21561130
• Report Number: 2021710-2015-01047
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2007
• 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
• Patient Outcome(s): Required Intervention