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

Model Number 3100A

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2014

Event Type  Injury  

Event Description

The customer reported that while in pt use on the following settings of map 12 cm, amplitude 30, hz 10.0 bias flow initially 15 lpm, they were unable to get a map any higher than 14 cm and this is after turning the bias flow up to 20 lpm or higher.The pt was removed from the ventilator and placed on another ventilator, no pt harm.

Manufacturer Narrative

(b)(4).The carefusion field service technician evaluated the ventilator and was unable to duplicate the reported issue.Performed 2k preventive maintenance check out procedure and unit passed all test per manufacturer specification.The customer was advised to return the pt circuit to carefusion for further analysis.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY/LSZ
• 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: 4462325
• MDR Text Key: 5189318
• Report Number: 2021710-2015-00116
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/23/2014

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
• Initial Date Manufacturer Received: 12/23/2014
• Initial Date FDA Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• 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