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

Model Number 3100A

Device Problem Failure to Cycle (1142)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2014

Event Type  Injury  

Event Description

The customer reported that the patient was connected to the oscillator and that during the touch time the oscillator failed and turned off.The respiratory therapist at the bedside attempted to reset the ventilator unsuccessfully.The patient was bagged at that point and the md and the nursing supervisor were notified.The patient was connected to conventional ventilator for approximately forty minutes.The oscillator was recalibrated and reconnected to the patient successfully.The customer reported that there was no patient harm and that the patient is now off ventilator support.

Manufacturer Narrative

The customer reported on their medwatch form 3500, that this is a product use error.However, the reporter listed in section e of this report, indicated to carefusion technical support should actually have been marked as 'product problem' instead of 'product use error'.The customer spoke with carefusion technical support and indicated that the ventilator is currently functioning properly.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: antonio cervera ; 7607787307
• MDR Report Key: 4355720
• MDR Text Key: 5177666
• Report Number: 2021710-2014-00071
• 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,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/08/2014

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
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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): Life Threatening; Required Intervention
• Patient Age: 18 DA